JB, a 23-year-old female, presented to the emergency department with fever, chills, nausea and abdominal pain. She was diagnosed with sepsis and treated initially with antibiotics and IV fluids. Her condition deteriorated after being transferred to a non-emergency ward, as key safety parameters like hypotension and elevated lactate were missed during handover. By Sunday, her symptoms met the criteria for septic shock, including low blood pressure, increased heart rate, and elevated lactate levels, indicating critical organ dysfunction from sepsis.
Cardiopulmonary Conditions Instructions(Must be included in pape.docxannandleola
Cardiopulmonary Conditions Instructions
(Must be included in paper and discussed in presentation)
1. What population is this condition typically found in?
2. How does the condition typically occur? What is the etiology?
3. What anatomical structures are involved?
4. What medical interventions are required?
5. What precautions or contraindications must the PTA be aware of during the patient’s medical treatment and/or during recovery?
6. What is the typical time frame for patient full recovery OR how long following medical intervention until the patient is considered able to return to full functional abilities (or return to PLOF).
7. What types of PT interventions are typically used to treat the condition during the:
a. acute phase
b. functional phase
8. Are there any recommended interventions that do not fall under the PTA’s scope of work?
9. Create an example daily treatment plan for the patient 3 weeks following injury/medical intervention based on information found during your research.
Running head: AN EXPLORE OF SARCOIDOSIS: MANAGING SARCOIDOSIS CONDITION
AN EXPLORE ON SARCOIDOSIS 2
AN EXPLORE ON SARCOIDOSIS
Student’s Name
Institutional Affiliation
An Explore on Sarcoidosis
Medical experts have discovered that sarcoidosis is a sequential ailment whose cause remains a mystery yet it presents varied and numerous forms of conditions, consequences, severity, and needs for medical attention especially treatments (Liu et al., 2014). Bearing in mind that sarcoidosis ailment associated with the development of tiny chains of inflammatory cells mainly in the lungs and lymph nodes as well as eyes and skin, the presentation of this condition could be typical or in many cases, they remain non-specific hence could mislead the diagnostic outcomes. The most significant case which could present this condition is the one with the forefront of pulmonary manifestations (Alicia, 2014). Consequently, the diagnosis depends on three common criteria which are not clinically common.
The Rates of Morbidity courtesy of Sarcoidosis
Scientific researches affiliated to the Sarcoidosis deaths in the States: 1999 to 2016 courtesy of the journal Respiratory Medicine explored that, America loses about 16,665 people through sarcoidosis. The data also revealed that the mortality rates had increased from 2.1 to 3 per 1 million persons in 1999 to 2016 respectively (Blankstein et al., 2014). These rates seemed to have increased from 2.1 to 3.1 from 1999 to 2002 and remained stable in the progressing years. The data also shows that patients within the age brackets of 35 years and above died courtesy of sarcoidosis with those between 65 to 75 years recording the highest rates of 8.5 deaths per 1 million while those between 75 to 84 years reporting nine deaths per 1 million (Liu et al., 2014). Either the rate of deaths among women patients increased by 32% (2.5 to 3.3 per 1 million patients while men morbidity increased by 73.3% (from 1.5 to 2.6 deat.
A Study On Clinical Profile Of Sepsis Patients In Intensive Care Unit Of A Te...dbpublications
Background : Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection which is one of the most important cause of mortality & morbidity in critically ill patients. In this study clinical profiles of the sepsis patients admitted in ICU in this part of India have been evaluated. Methods & Materials: This prospective hospital based observational study was undertaken in the department of Emergency Medicine ICU of Gauhati Medical College & Hospital, over a period of one year from August 2014 to July 2015 after obtaining institutional ethical committee clearance.
RESULTS: Clinical profiles of 50sepsis patients, with male preponderance (56%) & mortality rate 36% were studied. Mean age was 48.36 years (SD ±17.16). fever & tachycardia were present in all patients. 30 patients (60%) required ventilatory support, 28 patients (56%) required inotropic support, 10 patients (20%) required dialysis. Gram negative bacteria were found to be the predominant pathogens associated with sepsis(73.4%) where most common organism responsible was Klebsiella (36.8%). Conclusion : assessment of clinical signs & initial serological & radiological investigations are of utmost importance to detect more critically ill patients as early as possible to intervene earlier for saving the life of the sepsis patients.
Cardiopulmonary Conditions Instructions(Must be included in pape.docxannandleola
Cardiopulmonary Conditions Instructions
(Must be included in paper and discussed in presentation)
1. What population is this condition typically found in?
2. How does the condition typically occur? What is the etiology?
3. What anatomical structures are involved?
4. What medical interventions are required?
5. What precautions or contraindications must the PTA be aware of during the patient’s medical treatment and/or during recovery?
6. What is the typical time frame for patient full recovery OR how long following medical intervention until the patient is considered able to return to full functional abilities (or return to PLOF).
7. What types of PT interventions are typically used to treat the condition during the:
a. acute phase
b. functional phase
8. Are there any recommended interventions that do not fall under the PTA’s scope of work?
9. Create an example daily treatment plan for the patient 3 weeks following injury/medical intervention based on information found during your research.
Running head: AN EXPLORE OF SARCOIDOSIS: MANAGING SARCOIDOSIS CONDITION
AN EXPLORE ON SARCOIDOSIS 2
AN EXPLORE ON SARCOIDOSIS
Student’s Name
Institutional Affiliation
An Explore on Sarcoidosis
Medical experts have discovered that sarcoidosis is a sequential ailment whose cause remains a mystery yet it presents varied and numerous forms of conditions, consequences, severity, and needs for medical attention especially treatments (Liu et al., 2014). Bearing in mind that sarcoidosis ailment associated with the development of tiny chains of inflammatory cells mainly in the lungs and lymph nodes as well as eyes and skin, the presentation of this condition could be typical or in many cases, they remain non-specific hence could mislead the diagnostic outcomes. The most significant case which could present this condition is the one with the forefront of pulmonary manifestations (Alicia, 2014). Consequently, the diagnosis depends on three common criteria which are not clinically common.
The Rates of Morbidity courtesy of Sarcoidosis
Scientific researches affiliated to the Sarcoidosis deaths in the States: 1999 to 2016 courtesy of the journal Respiratory Medicine explored that, America loses about 16,665 people through sarcoidosis. The data also revealed that the mortality rates had increased from 2.1 to 3 per 1 million persons in 1999 to 2016 respectively (Blankstein et al., 2014). These rates seemed to have increased from 2.1 to 3.1 from 1999 to 2002 and remained stable in the progressing years. The data also shows that patients within the age brackets of 35 years and above died courtesy of sarcoidosis with those between 65 to 75 years recording the highest rates of 8.5 deaths per 1 million while those between 75 to 84 years reporting nine deaths per 1 million (Liu et al., 2014). Either the rate of deaths among women patients increased by 32% (2.5 to 3.3 per 1 million patients while men morbidity increased by 73.3% (from 1.5 to 2.6 deat.
A Study On Clinical Profile Of Sepsis Patients In Intensive Care Unit Of A Te...dbpublications
Background : Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection which is one of the most important cause of mortality & morbidity in critically ill patients. In this study clinical profiles of the sepsis patients admitted in ICU in this part of India have been evaluated. Methods & Materials: This prospective hospital based observational study was undertaken in the department of Emergency Medicine ICU of Gauhati Medical College & Hospital, over a period of one year from August 2014 to July 2015 after obtaining institutional ethical committee clearance.
RESULTS: Clinical profiles of 50sepsis patients, with male preponderance (56%) & mortality rate 36% were studied. Mean age was 48.36 years (SD ±17.16). fever & tachycardia were present in all patients. 30 patients (60%) required ventilatory support, 28 patients (56%) required inotropic support, 10 patients (20%) required dialysis. Gram negative bacteria were found to be the predominant pathogens associated with sepsis(73.4%) where most common organism responsible was Klebsiella (36.8%). Conclusion : assessment of clinical signs & initial serological & radiological investigations are of utmost importance to detect more critically ill patients as early as possible to intervene earlier for saving the life of the sepsis patients.
Availability of essential medicines in the Czech Republic (2017)Arete-Zoe, LLC
This report analyzes availability of essential medicines as defined in the World Health Organization (WHO) Essential List Medicines (Report of the WHO Expert Committee) in the Czech Republic. The WHO list of essential medicines contains most effective and safe medicines needed to meet the most important needs in health systems, and is frequently used by countries to create their own national lists. Without these drugs, some conditions will not be able to receive optimal therapy. Availability gap represents serious public health concern.
Expert Committee of the World Health Organization selects Essential Medicines Lists in accordance with approved procedures. The Committee evaluates the scientific evidence on the basis of the comparative effectiveness, safety and cost–effectiveness of the medicines. Both lists (adult and pediatric) went through major revisions in 2015, as the Committee considered 77 applications, including 29 treatment regimens for cancer, hepatitis C and tuberculosis (The Selection And Use Of Essential Medicines. Report Of The WHO Expert Committee, 2015).
Local availability is expressed as registration, in the form of total number of licensed products, and number of marketed products, i.e. products that were on the market in Q3 2016. Of the total number of 13,256 individual registrations for essential medicines, only 2,110 (14%) were actively marketed in Q3 2016. Total number of licensed and marketed product equals all strengths, formulations and dosage forms counted separately. The dataset is current as of December 30, 2016. Any revisions to the database made in the period between data download and publication of this report are not considered. Locally available products were compared to the WHO list of essential medicines. The material is presented in graphs and summary tabulations as listed in the table of contents.
Of the 427 essential drugs, 311 are registered in the Czech Republic, 292 were registered and marketed in Q3 2016, 19 were registered but not marketed, and 135 (32%) were unavailable. Most affected classes are antibacterials, antituberculars, antiretrovirals, antiparasitics, and dermatologicals. Essential medicines availability gap overlaps significantly with drugs that are in shortage globally.
The report provides overview of the situation in the Czech Republic. Essential medicines availability gap represents both public health concern and risk of harm to individual patients. Substitute and second line therapies are often less effective, more toxic, or more expensive. Improvisation and the use of less familiar medicines are more likely to lead to medication errors. Mitigation of shortages and creation of shared contingency supplies puts additional strain on understaffed hospitals, in addition to human toll inflicted by social stress. Drug shortages make it impossible to follow evidence-based practice guidelines, and force decisions to prioritize certain group of people over another.
Post-marketing safety surveillance of medical devices and drug-device combina...Arete-Zoe, LLC
ISoP Medical Device SIG Webinar on Post-marketing safety surveillance of medical devices and drug-device combination products
https://isoponline.org/special-interest-groups/medical-devices-group/
PMS is an integral part of a quality management system described in ISO 13485. ISO 13485 references inclusion of applicable regulatory requirements on post market surveillance into the quality management system.
Regulatory requirements are country specific and are continuously evolving. The regulatory processes for devices are significantly different than for drugs. Moreover, the requirements for drug-device combination products are not always clearly articulated.
• In Europe, according to the EU MDR, post-market surveillance shall also allow a comparison to be made between the device and similar products available on the market.
• The first challenge is identifying similar products on the market, that is out of the scope of this webinar. The second challenge is finding relevant information on equivalent and similar products.
• Since EUDAMED does not currently have a post-marketing module, manufacturers have to rely on a large number of national databases. The focus of this webinar is on regulatory requirements in major jurisdictions. There will be another webinar coming soon that will focus on how to obtain the information required to comply with all these requirements.
• With some effort, it is possible to locate information on advisory notices.
• However, adverse events or incidents are not publicly available. This is a major difference from medicinal products.
• In addition, certain AEs are subject to the National Competent Authority Report (NCAR) Exchange. These reports are shared between agencies and can potentially result in FSCA. So even when unable to monitor competitor product adverse event profile, it is important to know about their FSCAs.
More Related Content
Similar to Deteriorating Patient with Sepsis: Early Diagnosis and Intervention (2017)
Availability of essential medicines in the Czech Republic (2017)Arete-Zoe, LLC
This report analyzes availability of essential medicines as defined in the World Health Organization (WHO) Essential List Medicines (Report of the WHO Expert Committee) in the Czech Republic. The WHO list of essential medicines contains most effective and safe medicines needed to meet the most important needs in health systems, and is frequently used by countries to create their own national lists. Without these drugs, some conditions will not be able to receive optimal therapy. Availability gap represents serious public health concern.
Expert Committee of the World Health Organization selects Essential Medicines Lists in accordance with approved procedures. The Committee evaluates the scientific evidence on the basis of the comparative effectiveness, safety and cost–effectiveness of the medicines. Both lists (adult and pediatric) went through major revisions in 2015, as the Committee considered 77 applications, including 29 treatment regimens for cancer, hepatitis C and tuberculosis (The Selection And Use Of Essential Medicines. Report Of The WHO Expert Committee, 2015).
Local availability is expressed as registration, in the form of total number of licensed products, and number of marketed products, i.e. products that were on the market in Q3 2016. Of the total number of 13,256 individual registrations for essential medicines, only 2,110 (14%) were actively marketed in Q3 2016. Total number of licensed and marketed product equals all strengths, formulations and dosage forms counted separately. The dataset is current as of December 30, 2016. Any revisions to the database made in the period between data download and publication of this report are not considered. Locally available products were compared to the WHO list of essential medicines. The material is presented in graphs and summary tabulations as listed in the table of contents.
Of the 427 essential drugs, 311 are registered in the Czech Republic, 292 were registered and marketed in Q3 2016, 19 were registered but not marketed, and 135 (32%) were unavailable. Most affected classes are antibacterials, antituberculars, antiretrovirals, antiparasitics, and dermatologicals. Essential medicines availability gap overlaps significantly with drugs that are in shortage globally.
The report provides overview of the situation in the Czech Republic. Essential medicines availability gap represents both public health concern and risk of harm to individual patients. Substitute and second line therapies are often less effective, more toxic, or more expensive. Improvisation and the use of less familiar medicines are more likely to lead to medication errors. Mitigation of shortages and creation of shared contingency supplies puts additional strain on understaffed hospitals, in addition to human toll inflicted by social stress. Drug shortages make it impossible to follow evidence-based practice guidelines, and force decisions to prioritize certain group of people over another.
Post-marketing safety surveillance of medical devices and drug-device combina...Arete-Zoe, LLC
ISoP Medical Device SIG Webinar on Post-marketing safety surveillance of medical devices and drug-device combination products
https://isoponline.org/special-interest-groups/medical-devices-group/
PMS is an integral part of a quality management system described in ISO 13485. ISO 13485 references inclusion of applicable regulatory requirements on post market surveillance into the quality management system.
Regulatory requirements are country specific and are continuously evolving. The regulatory processes for devices are significantly different than for drugs. Moreover, the requirements for drug-device combination products are not always clearly articulated.
• In Europe, according to the EU MDR, post-market surveillance shall also allow a comparison to be made between the device and similar products available on the market.
• The first challenge is identifying similar products on the market, that is out of the scope of this webinar. The second challenge is finding relevant information on equivalent and similar products.
• Since EUDAMED does not currently have a post-marketing module, manufacturers have to rely on a large number of national databases. The focus of this webinar is on regulatory requirements in major jurisdictions. There will be another webinar coming soon that will focus on how to obtain the information required to comply with all these requirements.
• With some effort, it is possible to locate information on advisory notices.
• However, adverse events or incidents are not publicly available. This is a major difference from medicinal products.
• In addition, certain AEs are subject to the National Competent Authority Report (NCAR) Exchange. These reports are shared between agencies and can potentially result in FSCA. So even when unable to monitor competitor product adverse event profile, it is important to know about their FSCAs.
Sexual assault cases regularly make headlines and can potentially cause serious reputational harm to law enforcement agencies and police departments for mishandling the cases or not pursuing them vigorously enough.
The picture on the left shows the latest developments in a long-term problem of sexual assault on college campuses. In June, Candice Johnson, OCR Acting Assistant Secretary for Civil Rights issued a memo that effectively stalled investigation of civil rights violations including sexual assault on campuses. A month later, Democratic Senators Kirsten Gillibrand from New York State and Claire McCaskill from Missouri urged Secretary of Education Betsy Devos to reverse this decision as unlawful because of failure to protect students under Title IX. Full text of the memo and Title IX, Sec. 1681 Sex are part of your lesson handout.
Similar problem with widespread sexual assault, and especially against minors, is a long-term problem at cruise ships. Because of the nature of cruise ships, there is no immediate response by law enforcement and the ship guards that investigate the matter are the cruise company’s employees therefore often unlikely to be of meaningful help to the victims. Jurisdiction can be federal, state or foreign, depending on the ship’s flag.
Finally, sexual violence in a workplace can be difficult to address because of the unequal relationship between parties and under-reporting. Recently, car company Tesla appeared in the news as a hostile workplace to women.
Mitigating consequences of a drug-facilitated sexual assault .pdfArete-Zoe, LLC
Mitigating consequences of a drug-facilitated sexual assault
First published: 27 Jan 2017
Revised: 19 Jan 2020
Drug-facilitated sexual assault (DFSA) is not just bad sex. It occurs either without the victim’s consent or with consent that cannot be considered valid due to incapacitation of the victim by alcohol or drugs. While opportunistic DFSA is carried out once the victim has been rendered unconscious by own actions, pro-active DFSA describes situations when the perpetrator spikes the victim’s drinks covertly.
The most frequently used drug in DFSA is alcohol. Other drugs often involved include flunitrazepam (Rohypnol), gamma-hydroxybutyrate (GHB), gamma-butyrolactone (GBL), carisoprodol (Soma) and ketamine. Ecstasy (MDMA) and other benzodiazepines are occasionally used also. These drugs rapidly induce drowsiness, sedation and muscle relaxation. Typical symptom is decreased inhibition. Most of the drugs used for DFSA are odorless and tasteless, with the exception of GBL that has a bitter taste. Memoryy loss is common, most victims have little to no recollection of the previous night.
The most common way of obtaining these drugs is through the darknet. Benzodiazepines, GHB (Xyrem), and ketamine (an anesthetic used in human and veterinary medicine) are often diverted from legitimate medical use for illicit purposes.
In 2012, in U.S. v. Caronia became one of the landmark cases in the promotion of prescription drugs for unapproved (off-label) indications. Physicians who prescribe Xyrem (GHB) have to pass special certification to ensure safe prescription, handling, and storage of the drug (REMS).
Sedative or tranquilizer Flunitrazepam is still legally manufactured in Europe and some countries in Latin America. The drug has been reformulated, so it imparts an easily identifiable blue color to clear beverages and haziness to colored drinks. Drugs obtained from illegal manufacturing sources naturally do not display this effect.
DFSAs are increasingly popular in bars, clubs, and raves, but also fraternities and at college campuses. Mishandling of cases of sexual assault at college campuses has been subject to much criticism.
It is very difficult to estimate the total number of DFSAs. The main reason for failure to report sexual assault is the reluctance of the victims to go to the police. Indications exist that the numbers are on the increase. Because of memory loss associated with these drugs, victims often feel embarrassed or guilty. Additional reasons for not reporting sexual assault include need to avoid further stigmatization, especially when the evidence does not seem to be sufficient to support the claim confidently. Forensic evidence is difficult to obtain and often lost after first urination the morning after. All drugs used for DFSA are metabolized rapidly by the body, rendering them undetectable within 24 to 48 hours after ingestion.
Approach to preparing for a biological attack (2017)Arete-Zoe, LLC
Approach to preparing for a biological attack
June 2017
Hospital risk management series
The debate on critical issues in science, health, and security encompasses many controversies and ethical challenges. The difference between a naturally occurring outbreak and criminal act of bioterrorism is often challenging to establish, and emergencies have to be handled as they come, regardless of the origin of the incident. The post-incident forensic analysis may or may not offer satisfactory answers in regards to attribution, liability, and the responsibility for compensation. The underlying issue for all ethical concerns examined in this work is the balance between individual rights and the needs of public health systems to protect others.
Improving the resilience of vulnerable populationsArete-Zoe, LLC
Vulnerable populations in terms of health care disparities include the economically disadvantaged and uninsured, the elderly, and people with chronic health conditions. Low-education status compounds the problem and leads to poorer outcomes than in people with the same disease but higher educational status. Significant disparities include namely risk factors relating to morbidity and mortality and access to healthcare. In the domain of physical health, the worst affected are people with chronic health conditions such as respiratory diseases and metabolic syndrome, including hyperlipidemia and diabetes, and resulting in heart diseases and hypertension. Vulnerable populations often experience accumulation of problems that are multiplied by poor health, yet the medical and non-medical needs of these populations are still underestimated. A significant number of vulnerable people with at least one chronic condition skip purchasing prescription drugs because of the costs involved. The most relevant risk factors that result in poor access to health care include low income and uninsured status, in combination with a lack of regular care. Chronic conditions such as dyslipidemia may not be particularly apparent now, yet represent a high risk of future disability (“Vulnerable Populations: Who Are They?”, 2006).
Medical innovation, increasing the complexity of care, and the relationships between stakeholders gradually lead to the increase in prices of healthcare for consumers. Lack of transparency affects the cost of premiums as well as out-of-pocket expenses. Policymakers in their considerations need to include more indicators than just insurance coverage that, without other measures, will not curb soaring healthcare expenses. Delayed care is a public health concern because of the risk of disability and under-treatment of otherwise treatable conditions. The presentation of data to non-technical audiences, including decision-makers, has to be understandable to convey the information reliably. Systems modeling techniques should be considered to estimate stakeholder behavior in a dynamic system accurately. Currently, many instances of abuse exist within the system. As an example, chargemaster fees apply to uninsured or out-of-network patients. Hospital fees are, however, tackled by state laws rather than at the federal level. Consumers in health care tend to behave differently than in other industries and often think less about the costs involved. Physicians’ education should include the delivery of cost-conscious care to prevent financial harm to their patients. Transparency of cost is one of the most effective mechanisms that enable patients and providers to make informed choices.
Handling a high-risk HIPAA Breach Published April 2017 Part of scenarios for patient privacy crisis management Every hospital encounters patients, who for the reason of their social circumstances, dependent status, personal characteristics, or the nature of their condition, are more vulnerable than the general population. While compliance with HIPAA is indeed important, because of the potential to inflict significant liability on the hospital resulting from compliance failure, it should not be the only consideration when caring for vulnerable patients. Mere compliance with the minimum requirements of HIPAA does not guarantee the safety of vulnerable patients. In the case study scenario, the hospital emergency department in a small town admitted a 15-year-old female with emergency labor. After delivery in the emergency room, the mother and the baby were moved to Obstetrics and Neonate. Despite appropriate care, the infant presented with multiple medical problems, which may or may not be resolved in the future. A nurse, who took care of the young mother, accidentally disclosed the patient’s identity and condition to her young daughter, who spread the news in all high schools in the area by the following day. The 15-year-old managed to hide her pregnancy from her family. To complicate matters, the young mother’s mother and aunt work in the same hospital.
Addressing pediatric medication errors in ED setting utilizing Computerized P...Arete-Zoe, LLC
Pediatric patients who are treated in general acute care hospitals are at increased risk of medication errors. The main reasons are the lack of experience with the special needs of pediatric patients, their lower ability to tolerate medication errors, medication-related problems such as forms and packaging designed primarily for adults and labeling with insufficient information on the dosing of pediatric patients. Medication errors can be reduced significantly by appropriate medication management systems. Computerized Provider Order Entry (CPOE) systems reduce the frequency of medication errors in all stages of the process. IT technology introduces an additional vulnerability in the form of IT-related medication errors. Nurses are the last individuals in the medication management process who can detect and intercept a medication error and prevent incorrect medication orders from reaching and harming their patients. To be able to do so, nurses have to be familiar with the medication management system in their hospital and escalate incorrect orders as appropriate and relevant.
Let's talk causality attribution: Current practices and path forward Arete-Zoe, LLC
Consistent and reliable causality attribution at the case level is the cornerstone of confident signal detection.
The current practice relies on study investigators to establish causal relationships based on their observations. The Sponsor (Company) can add their assessment based on additional information about the drug. The current industry standard, E2B (R3), accounts for multiple assessment methods and presents the data elements for each drug-event pair evaluated by multiple sources in a matrix.
There are many causality assessment methods used within the industry, some universal, others more specialized. Most commonly used methods include WHO-UMC, Naranjo, Roussel-Uclaf (RUCAM) - to detect drug-associated liver injury, Karch and Lasagna, the French PV Algorithm, Bayesian Adverse Reactions Diagnostic Instrument (BARDI), MacBARDI, and Updated Logistic method. Expert judgment remains the most common method used.
Serious challenges prevent the practical implementation of existing algorithms by the industry. Many of the algorithms cannot be applied rigorously because of missing data. Additionally, an accurate definition of clinical harm is often lacking (e.g., peripheral neuropathy, vasculitis). Brighton Collaboration Case Definitions partly address this component.
Algorithms do not consider medication errors and are not easy to use with interactions, contributory causation, or secondary harms. Information obtained from the reporter is usually insufficient to establish a causal relationship, and follow-up requests for information must be sent, often repeatedly. The result is a very high share of unassessable reports and poor internal consistency of existing assessments.
I suggest modifying the ADE reporting to incorporate components enabling structured causality assessment directly by the reporting physician (postmarket) or investigator (clinical trials). Guiding questions would assist the reporting physician in determining causal relationships and facilitate algorithmic attribution upon submission:
Temporal relationship is a key component of causality assessment. Safety databases routinely calculate latency and last dose latency that feed the algorithm.
Dechallenge and Rechallenge represent key concepts in pharmacovigilance. This information is typically missing from reports. A series of questions regarding Outcome and Response (Action taken with drug) guide the reporting physician through a checklist for all suspect and interacting drugs, reliably and consistently calculating dechallenge/rechallenge for each drug-event pair.
Biological plausibility is a complex component requiring knowledge of the drug and the patient's medical condition.
Finally, it is important to ask the reporting physician about any underlying diseases that could have contributed to the event. A clear answer to this question is an essential component of the causality assessment algorithms.
Clinical documentation for medical devices Arete-Zoe, LLC
Clinical documentation for medical devices
Medical Devices Regulation (EU) 2017/745
We prepare EU MDR-compliant clinical documentation for medical device manufacturers for submission to notified bodies and national regulatory authorities.
EU MDR-compliant clinical documentation (English, Czech):
- Clinical evaluation (plan, report)
- Post-Market Clinical Follow-Up, -
- PMCF (plan, report, study design)
- Post-Market Surveillance System (plan, report)
- Clinical investigation design to complement existing evidence
- Biological Evaluation
- Literature review
Consulting
- Strategy how to generate clinical evidence
- Design of PMCF studies and clinical investigations
Additional support:
- Clinical expert for multiple medical specialties
- Risk management specialist
- Technical documentation
Zpracování klinické dokumentace dle EU MDR 2017/745 Arete-Zoe, LLC
Zpracování klinické dokumentace dle EU MDR 2017/745
- Strategie generování klinického důkazu
- Zpracování klinické dokumentace
- Design PMCF studií a zkoušek
- Návrhy aktualizací existující dokumentace
Služby
Poradenství
Strategie generování klinického důkazu
Design PMCF studií a zkoušek
Zpracování klinické dokumentace (ČJ, AJ)
Klinické hodnocení (plán/zpráva)
PMCF, PMS (plán/zpráva), PSUR
Biologické hodnocení
Návrh aktualizace související dokumentace
Stavba týmu dle potřeb zákazníka:
Klinický expert relevantní pro daný lékařský obor
Specialista na management rizika
Laboratoř na testování software, včetně AI/ML
Zpracování ostatních částí technické dokumentace
Klinické hodnocení (Plán, Zpráva)
Protokol literární rešerše
Biologické hodnocení
Post-Market Clinical Follow-Up (PMCF) (Plán, Zpráva)
Post-Market Surveillance (PMS) (Plán, Zpráva)
Periodic Safety Update Report (PSUR)
Anthrax is a serious infectious disease caused by the bacteria Bacillus anthracis. People or animals can contract anthrax from contact with infected animals or contaminated animal products. Bacillus anthracis forms spores than can survive in the environment, especially soil or animal products (e.g., rawhide) for decades. The most common route of exposure is via skin scrapes when working with infected animals resulting in cutaneous anthrax. Gastrointestinal infection occurs following eating raw or undercooked infected or contaminated meat. The most dangerous form of anthrax follows after inhalation of aerosolized anthrax spores, typically during industrial processing of infected animal products (e.g., rawhide, wool). In the United States, anthrax is very rare. Vaccination of livestock is recommended in areas with historical occurrences of anthrax. Moreover, all food animals are examined before slaughter (Mayo Clinic, Guide to Understanding Anthrax, ACIP).
Anthrax spores had been mass-produced as a bioweapon by the Soviet Union (STAT News). In 2001, anthrax was also used as a bioweapon when letters laced with anthrax were mailed to several news media offices and Democratic Senators Tom Daschle and Patrick Leahy, killing five and sickening 17 (Amerithrax investigation). Anthrax vaccine BioThrax is given to adults at increased risk of exposure in five doses, with a booster dose each year. It is also used as post-exposure prophylaxis in combination with antibiotics.
VAERS Explorer https://www.aretezoe.com/vaers-explorer
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Adenoviruses commonly cause respiratory illnesses ranging from the common cold to pneumonia, croup, and bronchitis, but also gastroenteritis, conjunctivitis, cystitis, or neurological disease. Adenoviruses have been a common cause of acute respiratory illness in military recruits. As non-enveloped viruses, adenoviruses are relatively resistant to common disinfectants. There are more than 50 types of immunologically distinct adenoviruses. People with weakened immune systems are at high risk of developing a severe disease caused by adenovirus infection (CDC, Health.mil). The vaccine is mandatory for all enlisted military recruits (Army Regulation 40-562).
Vaccine: Adenovirus Type 4 and Type 7 Vaccine, Live, Oral (US)
Pharmacovigilance Workshop
The workshop is designed to introduce pharmacovigilance to graduate students and working professionals interested in drug safety as a career field. After a brief introduction of publicly available data sources, each team received a case study that detailed a specific safety concern that resulted in a significant safety update of product labeling or product withdrawal.
Medicines may be withdrawn from markets because of risks to patients or business reasons. Change of benefit: risk profile is usually prompted by adverse effects that were either not previously detected, are more frequent, or more severe than anticipated based on the results of Phase III clinical trials. Market withdrawals are triggered by adverse events that were only made apparent from postmarketing surveillance data collected from population-wide use over more extended periods of time. The sources of information the regulatory agencies use when deciding on market withdrawal include meta-analyses and pooled analyses of data from clinical trials, clinical trials, spontaneous case reports, laboratory studies, observational studies, animal studies, and reviews of existing safety data.
In the U.S., individual case safety reports are collected in the FDA Adverse Event Reporting System (FAERS). In Europe, medication side effects are sent to national regulatory authorities and in the EU pharmacovigilance database EudraVigilance. The participants learned where to find clinical trials, market authorizations, and product labeling.
After the introductory presentation, each team received a case study that detailed a specific safety issue that resulted in a significant safety update of product labeling or product withdrawal. Each case study received product labeling and several scientific publications that discussed the safety concern in depth. Each team prepared a presentation with detailed overview of their assigned case study.
Are you interested in drug safety?
Try this for yourself!
Case studies:
Mylotarg (Gemtuzumab ozogamicin): no benefit, risk of death
Roaccutane (isotretinoin): teratogenic effect
Lariam (mefloquine): neuropsychiatric side effects
Zyprexa (olanzapine): stroke in patients with dementia
Avandia (rosiglitazone): myocardial infarction, death due to cardiovascular causes
Seroxat (paroxetine): suicidality
Xyrem (sodium oxybate): diversion, abuse
Coumadin (warfarin): bleeding
https://www.aretezoe.com/pharmacovigilance-workshop
The workshop is designed to introduce pharmacovigilance to graduate students and working professionals interested in drug safety as a career field. After a brief introduction of publicly available data sources, each team received a case study that detailed a specific safety concern that resulted in a significant safety update of product labeling or product withdrawal.
Medicines may be withdrawn from markets because of risks to patients or business reasons. Change of benefit: risk profile is usually prompted by adverse effects that were either not previously detected, are more frequent, or more severe than anticipated based on the results of Phase III clinical trials. Market withdrawals are triggered by adverse events that were only made apparent from postmarketing surveillance data collected from population-wide use over more extended periods of time. The sources of information the regulatory agencies use when deciding on market withdrawal include meta-analyses and pooled analyses of data from clinical trials, clinical trials, spontaneous case reports, laboratory studies, observational studies, animal studies, and reviews of existing safety data.
In the U.S., individual case safety reports are collected in the FDA Adverse Event Reporting System (FAERS). In Europe, medication side effects are sent to national regulatory authorities and in the EU pharmacovigilance database EudraVigilance. The participants learned where to find clinical trials, market authorizations, and product labeling.
After the introductory presentation, each team received a case study that detailed a specific safety issue that resulted in a significant safety update of product labeling or product withdrawal. Each case study received product labeling and several scientific publications that discussed the safety concern in depth. Each team prepared a presentation with detailed overview of their assigned case study.
Are you interested in drug safety?
Try this for yourself!
https://www.aretezoe.com/pharmacovigilance-workshop
Published April 2017
Part of hospital test scenarios, escalation to ethics committee
Patients with a terminal illness who communicate their wish to die to a nurse shall receive appropriate care that is in line with institutional procedures, local laws, and their personal preferences. A nurse should be able to rely on the support of the institution he or she works for in terms of training, clear line of responsibility for such decisions, and unambiguously communicated expectations defined in organizational procedures. Assisted suicide is legal in Switzerland and several other European countries, in several states in the U.S., and in Canada. The mental capacity of the patient has to be considered in addition to locally applicable laws. Medical Power of Attorney is helpful if the patient previously described his or her wishes regarding end-of-life decisions and became incapacitated in the meantime. Financial toxicity, in addition to dubious effectiveness, contributes to the reluctance of some patients to undergo aggressive and invasive therapies. German physician Albert Moll in his book Medical Ethics (1902), argues that aggressive care in incurably ill patients is unethical. Healthcare staff, including nurses, can conscientiously object to assisting with suicide.
Why merging medical records, hospital reports, and clinical trial data is a v...Arete-Zoe, LLC
Medical privacy and breaches of personal health information (PHI) has been a hot topic for several years. For the clinical trial industry, the main concerns are decline in recruitment resulting from lack of confidence in data handling and instances of breaches that affect data integrity that adversely affect NDA and MA applications in major markets, which precipitates administrative action taken by national regulators in response to local incidents.
European legislators rely extensively on administrative measures implemented by national competent authorities. Although specific and detailed EU-level legislation exists, specific information about data breaches, cases and incidents, volume and type of affected data, root causes and analysis of consequences is largely missing. According to Howard and Gulyas (2014), this lack of organized event records is currently an empirical obstacle but provides opportunity to generate new knowledge about data and privacy protection that could bolster future trial recruitment.
In the U.S., summary details of breaches that involved more than 500 individuals are available at the OCR portal called Wall of Shame for everyone to analyze. Disclosure obligations in HIPAA made the problem of data breaches in healthcare obvious and protection of the privacy of patients has been an important part of physicians’ code of conduct. This offers lessons learned to mitigate systemic vulnerabilities that undermine trial participation.
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
Basavarajeeyam is an important text for ayurvedic physician belonging to andhra pradehs. It is a popular compendium in various parts of our country as well as in andhra pradesh. The content of the text was presented in sanskrit and telugu language (Bilingual). One of the most famous book in ayurvedic pharmaceutics and therapeutics. This book contains 25 chapters called as prakaranas. Many rasaoushadis were explained, pioneer of dhatu druti, nadi pareeksha, mutra pareeksha etc. Belongs to the period of 15-16 century. New diseases like upadamsha, phiranga rogas are explained.
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
Basavarajeeyam is a Sreshta Sangraha grantha (Compiled book ), written by Neelkanta kotturu Basavaraja Virachita. It contains 25 Prakaranas, First 24 Chapters related to Rogas& 25th to Rasadravyas.
- Video recording of this lecture in English language: https://youtu.be/kqbnxVAZs-0
- Video recording of this lecture in Arabic language: https://youtu.be/SINlygW1Mpc
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Knee anatomy and clinical tests 2024.pdfvimalpl1234
This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
Deteriorating Patient with Sepsis: Early Diagnosis and Intervention (2017)
1. Deteriorating Patient with Sepsis: Early Diagnosis and Intervention
First published April 2017
Part of test scenarios for implementation of new sepsis guidelines
On Friday night, JB, a 23-year-old Caucasian female, presented at the emergency department with fever,
chills, malaise, nausea, increasing confusion, and mild diffuse abdominal pain. Sepsis was suspected
because of elevated temperature at 38.9˚C, elevated respiratory rate at 20 breaths per minute, and
signs of generalized infection. The study follows the patient's condition, her development, diagnostic
steps, and significant findings that led to the establishment of the diagnosis and decision which
interventions to use. Full description of the patient’s condition at transfer to a non-emergency ward is
described in Identification, Situation, Background, Assessment, and Recommendation forms (ISBAR)
chart that is included in Appendices. In 2016, the Surviving Sepsis Campaign (SSC) prepared new revised
International Guidelines for Management of Sepsis and Septic Shock (2016) (Surviving Sepsis Campaign).
The progression and management of sepsis and septic shock are explained utilizing the new 2016
Surviving Sepsis Guidelines as published by Rhodes et al. (2017).
Sepsis: definition, assessment, and management
The definition of sepsis and septic shock has changed multiple times in the last three decades to reflect
new research and clinical observations. As of 2016, sepsis is defined as a "life-threatening organ
dysfunction caused by a dysregulated host response to infection" (Kleinpell, Schorr & Balk, 2016). The
new diagnostic criteria for sepsis consist of an alteration of mental status, expressed as GCS score at 13
or below, a decrease in systolic blood pressure below 100 mm Hg, and respiration rate higher than 22
breaths per minute. A patient with two or more qSOFA criteria should be examined for organ failure
(Seymour et al., 2016). The qSOFA tool is not meant to replace previously developed tools but to be
used in addition to them. Systemic Inflammatory Response Syndrome (SIRS) significantly overlaps with
sepsis and systemic infection (Vincent, Martin, & Levy, 2016).
The initial clinical assessment was made using the Australasian Triage Scale (ATS) approach. The Primary
survey is aimed at the identification of life-threatening conditions, whilst the Secondary Survey includes
a full set of vitals, comfort measures, and head-to-toe assessment (Brown, 2013). JB, a 23-year-old
Caucasian female, presented at the emergency department on Friday night with fever, chills, malaise,
nausea, and mild diffuse abdominal pain. The initial examination revealed heart rate at 92 bpm, SpO2 at
100%, blood pressure 140/70 mm Hg, respiratory rate 20 breaths per minute, and temperature 39.9˚C,
steady regular symmetric pulse, petechial rash and adequate skin perfusion with CRT 1.5 sec. Her
consciousness was assessed as 14 at the Glasgow Coma Scale (GCS) due to confusion and lethargy. The
patient appeared breathless and somewhat incoherent when talking. The patient was hemodynamically
stable. The condition was consistent with a generalized infection, although it did not meet the qSOFA
standard for sepsis.
Early recognition of sepsis is essential for treatment success through screening. Core sets of
recommendations issued by the Surviving Sepsis Campaign include routine obtaining microbiologic
cultures, including blood, before starting antimicrobial therapy, providing doing so results in no
substantial delay in care. Isolation of the pathogen allows the de-escalation of antimicrobial therapy
(Rhodes, 2016).
Initial management of a patient with sepsis includes the stabilization of hemodynamic parameters by
the administration of crystalloids and a concerted effort to identify the offending agent. The treatment
2. of sepsis is organized into two recommendations called "bundles": the initial management that takes
place within six hours after the presentation for care, and the management bundle that takes place in
the intensive care unit (Dellinger et al., 2013).
The goals of the initial bundle are to lessen the immediate impact of uncontrolled infection and to assist
the cardiac and respiratory systems through the use of intravenous administration of fluids and
vasopressors and administration of oxygen therapy. Early diagnosis and aggressive resuscitation therapy
are of critical importance — delayed or inappropriate antibiotic treatment results in higher mortality
rates (Paul et al., 2010).
Once the samples for blood cultures and other parameters are collected, intravenous antibiotics shall be
administered to cover all possible sources of infection. The choice of antibiotics depends on the
suspected pathogen and its virulence and resistance patterns. The revised guideline recommends the
administration of initial antibiotic treatment within an hour of diagnosis of sepsis or septic shock after
the blood culture samples were taken. The combination of antibiotics shall then be adjusted according
to the laboratory findings ("Surviving Sepsis Campaign").
Empiric broad-spectrum antimicrobial therapy is recommended to cover all likely pathogens.
Antimicrobial therapy shall be revised and narrowed once the offending agent has been identified and
sensitivity established, or if adequate clinical improvement occurs. The revised guideline suggests
lowering of doses of antimicrobials and adjustment to the patient’s organ functions to ensure optimal
pharmacokinetic and pharmacodynamics profile and decrease side effects (Rhodes, 2016).
The most common bacteria isolated from patients with sepsis include Staphylococcus aureus (S.
aureus), Streptococcus pyogenes (S. pyogenes), Klebsiella spp., Escherichia coli (E. coli),
and Pseudomonas aeruginosa (P. aureginosa). Pathogens isolated from seriously ill patients display a
wide array of virulence factors such as endotoxins, lipopolysaccharides, exotoxins and enterotoxins.
Bacterial toxins modulate host cell defenses and allow the spread of infection throughout the body
(Ramachandran, 2013).
JB was started on crystalloids at 30 mL/kg, a combination of two broad-spectrum antibiotics, and low
flow oxygen closely monitored for any changes in hemodynamic parameters. Blood cultures, taken
before the first administration of antibiotics, revealed the presence of Gram-positive cocci, eventually
identified as Streptococcus pyogenes. The initial procedures were aimed at the localization of the source
of infection. Ultrasound of abdomen, pelvis, and chest X-rays did not show any abnormalities.
Cerebrospinal fluid was sterile. During the initial series of examinations, the patient became increasingly
confused and lethargic. Chronic skin infection previously diagnosed as acne and unspecified joint pain
were suspected as the most likely sources of the generalized infection. At this stage, the patient was still
hemodynamically stable. The full description of the patient’s condition is in the ISBAR chart, Appendix 1.
Handover: diagnostic tests and safe parameters
Intra-hospital transfers of critically ill patients lead to increased risk of adverse events. Incidents were
most likely related to equipment failure and physiological deterioration of the patient, including
hypotension and hypoxia. The number of incidents can be reduced through the implementation of
standardized protocols, procedures, and checklists relating to patient condition, personnel roles and
responsibilities, and organization and equipment and information exchange (Brunsveld-Reinders,
Arbous, Kuiper, & de Jonge, 2015). An example of such a checklist presented by Silva and Amante (2015)
3. includes a comprehensive review of the patient’s condition before, during, and after the intra-hospital
transport.
Due to multiple other medical emergencies that night, some of JB’s essential readings were not
performed and recorded. The nurse who was accepting the transfer of the patient to her noticed that
there were no new test results and no record of monitoring from the night before. The two most
critically important measures in this particular instance were slowly progressing hypotension, significant
because of a trend rather than absolute value, and hypoxemia expressed as blood lactate level.
Mean arterial pressure is the critical indicator for the initiation of vasopressor treatment. Patients with
mean arterial pressure (MAP) below 65 mm Hg shall be started on vasopressors such as norepinephrine
and titrated up to 35-90 μg/min (Dellinger, Schorr, & Levy, 2017).
The high level of lactate is defined as > 4 mmol/L. In shock states, the elevation of lactate is caused by
hypoperfusion and resulting tissue hypoxia. The functional cause of hypoperfusion is macro and
microcirculatory dysfunction and mitochondrial dysfunction. The patient presentation shows a
hypermetabolic state (Andersen et al., 2013). Blood lactate levels in septic patients are the indicator of
cellular metabolic failure and low tissue oxygenation rather than global hypoperfusion. Lactate is the
most important indicator in patients with sepsis because of its implications on treatment decisions. All
patients with elevated lactate > 4 mmol/L (36 mg/dL) shall be treated for septic shock regardless of
blood pressure (Dellinger, Schorr, & Levy, 2017).
The rationale for transfer to a non-emergency ward was that the patient no longer met the MET criteria
while on medication that could be administered elsewhere. Her normalizing body temperature at 37˚C
was misinterpreted as a sign of recovery from the infection. Her blood pressure was 90/60 mm Hg,
respiratory rate at 18, and she was˚ alert. Ominous trends that would suggest otherwise were not
available. Accurate and current clinical assessment is essential for a clinician to be able to make a
decision whether or not the patient can be transferred to non-emergency care. In JB’s case, the patient’s
dropping temperature was misinterpreted as improvement and a sign of a clearing infection rather than
a symptom of developing sepsis. However, it would be incorrect to blame a nurse at ICU for failure that
is of organizational nature. Comprehensive checklists and protocols relevant to patient transfer would
substantially improve patient safety.
Septic shock: pathophysiology and assessment
“Septic shock is a subset of sepsis in which circulatory, cellular, and metabolic alterations are associated
with a higher mortality rate than sepsis alone” (“Surviving Sepsis Campaign”). Septic shock is the result
of the maldistribution of blood flow. Hypo-perfusion of tissues leads to tissue hypoxia, metabolic
acidosis, the release of cytokines and oxygen free radicals, and cell death. The dysfunction of multiple
organ systems is quickly followed by multiple organ failure if the process is not halted. Systemic
Inflammatory Response Syndrome (SIRS) is characterized by elevated or lowered white blood cell count
or an increase in immature neutrophils (bands). Resulting progressive sepsis-related organ dysfunction is
called Multiple Organ Dysfunction Syndrome (MODS) (Kleinpell, Schorr & Balk, 2016).
Septic shock is the most critical stage of sepsis and results in the highest mortality rates. When the
infection is cleared, and tissue recovers, organ injury and secondary infections may occur. It is important
to understand that sepsis involves inflammatory, hemodynamic, tissue-perfusion, and organ dysfunction
variables, with the potential to advance to organ dysfunction. The complexity of sepsis and the possible
deterioration of septic shock are dependent on the virulence and load of the causative pathogen and
the present state of health and genetics of the host. Pro-inflammatory reactions that attack the
4. pathogen are responsible for parallel tissue damage. Anti-inflammatory responses limit tissue injury, but
also promote susceptibility to secondary infection (Angus, & van der Poll, 2013).
Septic shock develops in patients who remain hypotensive despite the administration of vasopressors
and whose serum lactate levels increase above 2 mmol/L despite adequate fluid resuscitation. Tissue
hypo-perfusion results in hypoxia, which triggers a cascade of biochemical processes within the cell due
to anaerobic metabolism and the resulting production of lactate. Release of cytokines, namely tumor
necrosis factor-alpha (TNF-α), interleukin-1 (IL-1), and other pro-inflammatory mediators, leads to
increased permeability of membranes and leakage of intravascular fluid into interstitial space. Some
bacterial toxins activate the same cascade. Activation of interleukins 6 and 8 (IL-6 and IL-8) leads to the
release of platelet-activating factor and formation of micro-thrombi within the vascular system. The
combination of these factors results in the impaired distribution of blood volume, vasodilatation, and
hypoperfusion — resulting in tissue hypoxia, which further exacerbates and worsens the problem.
Activation of the central nervous system and hypophyseal-adrenocortical axis leads to hypermetabolic
state, increasing tissue demand for oxygen. The effect of TNF-α and IL-1 on the myocardium is the cause
of depressed myocardial function, decreased ejection volume, and worsening hypotension.
Hypovolemia leads to centralization of blood circulation, limiting the flow of blood in the kidneys and
mesenterium, causing additional complications such as acute kidney injury (Brown, 2013).
Indicators of septic shock include persisting hypotension below 65 mm Hg despite vasopressors use, and
blood lactate > 2 mmoL/L despite adequate volume resuscitation (Seymour et al., 2016). Lactate is the
product of anaerobic metabolism, produced by most cells in the human body. Under anaerobic
conditions, it is the end-product of glucose metabolism. Under normal conditions, lactate is rapidly
cleared from the bloodstream by the liver. Elevated lactate is defined as 2 to 2.5 mmol/L by different
sources. The high level of lactate is defined as > 4 mmol/L. The term lactic acidosis shall be used if the
patient has high lactate and pH<7.35. In shock states, the elevation of lactate is caused by hypoperfusion
due to macro and microcirculatory dysfunction, mitochondrial dysfunction, and the presence of a
hypermetabolic state (Andersen et al., 2013). Blood lactate levels in septic patients are the indicator of
cellular metabolic failure and low tissue oxygenation rather than global hypoperfusion. Although lactate
does not provide a full picture of metabolic status as blood gases do, it is considered as the most
important indicator in patients with sepsis because of its implications on treatment decisions. All
patients with elevated lactate > 4 mmol/L (36 mg/dL) shall be treated for septic shock regardless of
blood pressure (Dellinger, Schorr, & Levy, 2017).
Accurate and rapid assessment is vital to halt the progression of the sepsis into septic shock. The patient
may or may not present with symptoms of bacteremia with or without complications such as acute
respiratory distress syndrome (ARDS), acute kidney injury (AKI), disseminated intravascular coagulation
(DIC), myocardial ischemia and dysfunction, mesenteric ischemia and other complications relating to
hypo-perfusion and organ dysfunction (Kalil and Bailey, 2016).
Invasive monitoring of patient conditions in septic shock is possible through the use of transpulmonary
thermodilution (Saugel et al., 2016). The technique is performed through the insertion of a central
venous catheter into the inferior or superior vena cava; a thermistor-tipped arterial catheter is usually
placed through the femoral artery into the abdominal aorta (Bendjelid, Giraud, Siegenthaler, & Michard,
2010). Cooled saline is introduced into the central venous circulation and passes through the right heart,
pulmonary circulation, and the left heart. Then the thermistor detects the thermal indicator bolus of
sale at the end of the arterial catheter, allowing the realization of a curve that shows how the cold
indicator is diluted through the patient’s cardiopulmonary circulation. Other hemodynamic values
5. available are CO assessment, cardiac preload, myocardial contractility, and the extravascular lung water
index (Kiefer et al., 2012; Tagami et al., 2010 and Casserly, Read, & Levy, 2011).
After transfer, JB’s GCS was still 13; her blood pressure dropped to 90/60 mm Hg heart rate increased to
141 bpm, and the temperature dropped to 37˚C and continued to drop. Her pulse was weak and narrow,
and respiratory rate > 22 breaths per minute. Peripheral capillary oxygen saturation (SpO2) dropped to
90%. Her skin turned very pale and showed signs of hypo-perfusion and edema. Laboratory findings
included leukocytosis, neutrophilia with a left shift, and hyperglycemia. JB’s qSOFA score increased from
one on the Friday night to three by Sunday mid-day when she developed tachypnea and systolic
hypotension in addition to the Glasgow Coma Scale score (GCS) of 13. JB’s condition indicated that she is
developing septic shock. She was hypotensive, and her mean arterial pressure (MAP) was dropping, and
her lactate level was 3.5 mmol/L. By Sunday night, JB was unable to void despite high fluid intake.
Oliguria increased creatinine and blood urea nitrogen, and electrolyte imbalance pointed to kidney
dysfunction. Moreover, JB started showing signs of dyspnea. Using the Berlin Definition, her ADRS was
200 mm Hg and PaO2/FIO2 ≤ 300 mm Hg, which qualifies as mild (Ranieri, Rubenfeld, Thompson, & et
al., 2012).
Septic shock: management
It is essential to ensure good perfusion and oxygenation of tissues. It is key to halt the deterioration of a
patient with sepsis into septic shock and prevent additional tissue injury. A patient with sepsis-induced
hypotension or lactate above 4 mmol/L shall receive a rapid infusion of crystalloids and low flow oxygen.
Patients with pneumonia or acute lung-injury may require high flow oxygen and intubation or
mechanical ventilation. When large volumes of crystalloids are required, supplementation of albumin
fluid should be considered to maintain intravascular volume. The septic shock is characterized by
hypotension that has not responded to previous efforts at fluid resuscitation. The first consideration is,
therefore, the use of vasopressors. The current vasopressor of choice is norepinephrine to maintain a
MAP of ≥65 mmHg, followed by vasopressin, epinephrine, and phenylephrine (Rhodes et al., 2016 and
Pittman, 2016)
Patients with mean arterial pressure (MAP) below 65 mm Hg shall be started on vasopressors such as
norepinephrine and titrated up to 35-90 μg/min. Once stabilized, norepinephrine can be continued
alone or in combination with vasopressin at 0.03 units/min, and the dose of norepinephrine can be
gradually decreased. If the patient continues to deteriorate, epinephrine and phenylephrine can be
added to achieve the MAP target (Dellinger, Schorr, & Levy, 2017).
Care must be taken to avoid excessive fluid resuscitation, as a negative fluid balance is preferred with
sepsis patients; particularly in patients with ARDS, negative fluid balance improves organ function
(Saugel et al., 2016).
The new guidelines suggest the use of dobutamine only patients with low risk of tachycardia and only in
low doses for renal protection. Attempts to increase cardiac output with dobutamine did not improve
outcomes. Dobutamine, and to a limited extent some other inotropes, may improve tissue perfusion
through increasing oxygen delivery (Rhodes et al., 2016).
Recommended interventions include prophylaxis of gastric ulcers and venous thromboembolism and
insulin for glucose control. Other interventions, such as sedation or dialysis, are reserved for special
situations. It is of critical importance to locate the source of infection. Corticosteroids, immunoglobulins,
6. blood purification, administration of blood products, bicarbonates, parenteral nutrition, and inotropes
are not recommended in patients with septic shock (Rhodes, 2017).
JB did not initially respond to norepinephrine but eventually stabilized when vasopressin and
epinephrine were added to the infusion. Oxygen was administered per nasal cannula. Antibiotic
treatment was adjusted to kidney function and to target Gram-positive cocci. Because of a large volume
of crystalloids and continuing extravasation, she received albumin to maintain intravascular volume. A
central venous catheter capable of hemodynamic measuring was inserted to enable peripheral access
and administration of intravenous fluids. To normalize her blood glucose levels, she received insulin.
Conclusion
Sepsis is a serious condition that still has a high mortality despite advanced care. The key to successful
treatment is early diagnosis and aggressive treatment. Recently revised treatment guideline offers an
excellent opportunity to review hospital practices in regards to the diagnosis and early aggressive
treatment of sepsis and septic shock. Screening for infections, including blood cultures, facilitates early
diagnosis and enables timely intervention. The case scenario presents a relatively low-risk patient
demographic presented with symptoms that could have been easily misdiagnosed. The clinical
symptoms corresponded with sepsis and rapidly progressed into septic shock. The patient benefited
from early diagnosis and aggressive intervention based on newly revised guidelines, and the fact that
these guidelines were implemented in clinical practice with fidelity. However, the patient later
deteriorated during a poorly controlled intra-hospital transfer that was signed off by a nurse who used a
standard that should not have been applied in this situation, consequently causing a delay in the
detection of deterioration and delayed care. Whilst the case shows evidence-based medicine at its best,
more can be done at the organizational level to facilitate communication during transfers, hospital
information management during handovers, including the design of checklists and application of
appropriate standards as well as roles and responsibilities for standard situations.
References
Andersen, L., Mackenhauer, J., Roberts, J., Berg, K., Cocchi, M., & Donnino, M. (2013). Etiology and
Therapeutic Approach to Elevated Lactate Levels. Mayo Clinic Proceedings, 88(10), 1127-
1140. http://dx.doi.org/10.1016/j.mayocp.2013.06.012
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