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Controlling ICU Agitation; Context Determines Strategy Ways to Facilitate Knowledge Transfer

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  • 1. Controlling ICU Agitation; Context Determines Strategy Gil Fraser, PharmD, FCCM Ways to Facilitate Knowledge Transfer Critical Care, MMC Professor UVM College of Medicine fraseg@mmc.org
  • 2. Some Things Are Easy • Job(s) 1 = Patient comfort, patient and care-giver safety, maintenance of oxygenation and perfusion • Assume accumulation of parent drug (lorazepam and midazolam) and active metabolite (midazolam) with prolonged use • Don’t complicate things – Avoid deliriogenic drugs – Avoid propofol and dex with high dose vasoactive therapy • Initiate home medications when appropriate
  • 3. It’s Gotten a Bit Complicated
  • 4. ICU Sedation Literature Citations vs Time 2000 1838 1800 1576 1600 1400 1200 Citations 991 1000 800 613 600 400 197 200 80 85 8 0 1960-9 1970-9 1980-4 1985-9 1990-4 1995-9 2000-4 2005-9
  • 5. Managing ICU Agitation Is NOT Easy Maldonado. Crit Care Clin 2008;24:789
  • 6. Facilitating Rapid Knowledge Transfer to the Bedside • Options – Use clinical practice guideline as a model – Create “bundles” for implementing essential components of practice guidelines – Develop protocols for managing pain/agitation/delirium – Offer real time clinical decision support • ADAPT then ADOPT previously developed tools
  • 7. New Sedation Guidelines! Will be published in 2010 Recommendations per GRADE methodology
  • 8. Clinical Practice Guidelines (CPG) The Temptation of Simplicity Appreciating the Thinness of Ice • Temptation: – Defer to identified experts for objective evaluation of issues and controversies – Use their simplified algorithms for management strategies • Management decisions should be – Individualized within the context of the treated patient • Problem: – Rush to incorporate vulnerable data into CPGs and quality improvement efforts
  • 9. What to Do?? No desire to cast aspersions on CPGs or bundles Understand their limitations Do not blindly accept all recommendations Base clinical decisions on individual patient context Use most recent rigorous data to assess risk:benefit
  • 10. Your Job for Today • Value protocolized pain/agitation/delirium management • Understand new data that redefine risks and benefits of drug management strategies • Evaluate various strategies for beside implementation of best practice • Become completely confused about ICU delirium—defer to Dr. Devlin
  • 11. Importance of Protocolization • Helps bring “best practice” to the bedside • Limits practice variation • Reduces delays in management – Encourages regular assessment of pain, agitation, delirium – Facilitates pharmacologic interventions: drug choice, dosing, titration
  • 12. Surveys of ICU Sedation Practices • In the US, 64% use protocol, with 40% using daily interruption. • In Canada, 29% use protocol, 40% use daily interruption. • Adherence to protocols ~50%
  • 13. Why Are Protocols Not Used? ICU patients and protocols are too complex
  • 14. Sedation/Analgesia Algorithm for Ventilated Patients
  • 15. Intermittent Preprocedural Anxiety Delirium Sustained SAS 3 or 4 SAS 1 or 2 •Mechanically Ventilated •Frequent Neurologic Evaluation is Necessary •High Dose Vasopressors and Mechanically Ventilated •Frequent Neurologic Evaluation Not Necessary •Not Mechanically Ventilated •High Dose Vasopressors and Not Mechanically Ventilated •GABA Agonist Withdrawal •Delirium •Renal Disease Over 150 •Liver Disease possible •Refractory Agitation clinical scenarios
  • 16. Why Are Protocols Not Used? • Too complex • Determination of adequacy of sedation remains subjective – How deep is too deep? – Is deep just right?
  • 17. Deep Sedation • Greater than 40% patients are more deeply sedated than desired • Drug-induced coma present during 32% of patient evaluations – Yet only 2.6% rated as “oversedated” Weinert. CCM 2007:35:393 Does This Payen. Anesthesiology 2007:106:687 Matter? Martin. ICM 2006; 32:1137
  • 18. Non- Factors Supporting Deep evidence Sedation = Humane Treatment based • Lying in a sleep-like state without motor activity = comfortable patient • The ICU experience is inhumane – The ability to form factual memories is cruel • Could even lead to PTSD – Amnesia of the ICU experience is desired
  • 19. Avoiding Coma Impacts Outcomes What about long-term outcomes? Fraser and Riker. CCM 2007; 35:635
  • 20. Depth of Sedation? Periscope depth “PTSD was highest in the middle level of wakefulness and lowest when least aroused or the most awake.’ Griffiths. CCM 2008; 36:945 To the ocean floor
  • 21. ICU Pain and Discomfort
  • 22. Pain and/or Discomfort Should ALWAYS Be Considered a Cause of ICU Agitation • “Mundane/routine” aspects of ICU care are the most troublesome for patients 1990 63% remembered moderate to severe pain Puntillo. Heart Lung 1990; 19:526 2007 50% remembered unmet analgesic needs Gelinas. Intensive Crit Care Nurs 2007; 23:298 There has been little progress despite 17 years of focused attention on pain as an important clinical issue
  • 23. New Paradigm: Analgesia-based “Sedation” Crit Care 2005; 9: R200 , Crit Care 2004; 8:R1, Anesthesiology 2004; 101:640, Br J Anaesth 2007; 98:76, ICM 2009; 35:291 • Also known as analgosedation or analgesia- first (A-1) sedation • Acknowledges that discomfort is a common cause of agitation • Continuous infusion remifentanil or fentanyl – Rapid onset and offset • ~ 50% will require additional sedation
  • 24. Redefining the Roles of Available Sedative Agents • A very selective review of data – Dexmedetomidine – Benzodiazepines – Propofol
  • 25. Dex Dose, Duration, and Downsides 61% required more than 0.7mcg/kg/h Duration up to 15 days Riker. JAMA. 2009; 301:489-99.
  • 26. Time to Successful Extubation ≠ Shorter ICU Stay Absolute Time to Dexmedetomidine Midazolam P Reduction Extubation (n=244) (n=122) value (%, days) Median 3.7 days 5.6 days 32.2% 0.01 (95%CI) (3.1 – 4.0) (4.6-5.9) 1.9 days Absolute ICU LOS Dexmedetomidine Midazolam P Reduction days (N=244) (N=122) value (%), days Median 5.9 days 7.6 days 22.3% 0.24 (95%CI) (5.7 - 7.0) (6.7 – 8.6) 1.7 d Riker. JAMA. 2009; 301:489-99.
  • 27. Pearls For The Use of Dex • Do not use loading dose • Expand dosing range to 0.1-1.4mcg/kg/hr • Expand permissible treatment duration >24h • Anticipate dex-induced hemodynamic instability and bradycardia • Combine with other sedative or analgesic agents as needed • Transition to clonidine
  • 28. 30 Minute Dexmedetomidine Dose Adjustments Reduce Hypotension Gerlach. J Crit Care 2009; 24:568
  • 29. ICU Costs Comparing Dexmedetomidine vs Midazolam It’s a Matter of Time and Ability to Discharge • % time at target sedation range: midazolam = dexmedetomidine (JAMA 2009; 30:489) • Blinded evaluation of costs of care – ICU length of stay, time on vent, drug costs, and cost of adverse reactions using cost minimization analysis • Median savings: dex vs midazolam – Median drug costs: Dex = $1826, Midazolam = $60 – Primary drivers of cost savings = ICU stay and time on the ventilator; ~ $6K and $3K respectively – $9,679 (95% CI = $2,314-17,045, p = .01) Dasta. CCM 2010 epub ahead of print
  • 30. Benzodiazepines
  • 31. Sedative Infusions: Propofol >> Benzodiazepines Wunsch. CCM 2009 (Project IMPACT) 50% receive continuous Propofol infusion use infusion sedation; most increasing, not lorazepam propofol, 30% = benzo
  • 32. Benzodiazepine Concerns: Delirium Benzodiazepines • Independent risk factor for development of delirium • Especially if used to induce even brief periods of coma Pandharipande. Anesthesiology 2006; 104:21 and J Trauma 2008; 65:34 Ouimet. ICM 2007; 33:66
  • 33. Lorazepam as a Source of Propylene Glycol (PG) • PG toxicity – Metabolic acidosis, hyperosmolality, acute kidney injury – Osmol gap of >10-12 may serve as surrogate for propylene glycol accumulation in patients receiving > 1mg/kg/d lorazepam 80% of a vial of lorazepam is PG Yahwak. Pharmacotherapy 2008: 28:984
  • 34. Propofol
  • 35. Propofol: Concerns • NO analgesia! – 25% receive opiate infusion while on propofol vs 66% with benzo infusions Wunsch 2009 CCM • Hypotension • Hypertriglyceridemia; lipid source (1.1 kcal/ml) – Monitor triglycerides twice weekly • Respiratory depression • Propofol Infusion Syndrome (PRIS)--rare, but often fatal • Asystole/bradycardia, cardiovascular collapse, rhabdomyolysis, and severe metabolic acidosis • Caution should be exercised at doses >80mcg/kg/min for more than 48 hours—also seen at lower doses within a few hours of initiation • Most commonly reported in patients also receiving catecholamines and/or steroids • Discontinue propofol in the setting of unexplained bradycardia or metabolic acidosis
  • 36. PRIS: More Common Than Thought? Iyer. CCM 2009; 37 epub • 11 year review of refractory status epilepticus pts • Outcomes in the propofol treated group (N = 31) – PRIS features occurred in 39% • 20% of this cohort (N= 3) developed life-threatening cardiac arrest ----2 died. – Peak propofol dose in these patients = 141 vs 60mcg/kg/min in noncardiac arrest PRIS patients. • None of the PRIS features occurred in patients who did not receive propofol
  • 37. ICU Agitation Management • Homemade or canned? – Doesn’t matter as long as the essential ingredients are included • Management strategies are context/patient specific – Probable reason for agitation • Pain • Withdrawal • Anxiety • Delirium – Other modifiers • Intubated vs not • Short vs long-term sedation • Organ dysfunction: heart, brain, liver, and kidney • Deep vs light
  • 38. Tools to Facilitate Bedside Application • Order sets based on agreed-upon institution specific protocols • Real-time clinical decision support • Bundles imbedded with data feedback
  • 39. Real-Time Clinical Decision Support Tools Once modifiers are selected, all orders appropriate for this patient become available
  • 40. Sedation, Analgesia, Delirium (SAD) Bundle Make your own “bundle” with elements and metrics 1. Screen for the presence of pain, agitation, and delirium and accurately document on a consistent basis • How often is this documented each day? 2. Insure that measures to prevent and treat pain, agitation, and delirium are a part of routine ICU care • Adhere to institution-specific protocols • Provide analgesia prior to procedure associated with pain • Provide management < 0.5 h of discomfort or agitation • Achieve sedation goal without coma or dangerous agitation • Document strategies to prevent delirium each day 3. Monitor the effectiveness of these strategies • % time spent in drug induced coma (SAS 1-2) • % patients reporting moderate to severe pain • % SBT stalled due to under and over-sedation • ICU ventilator time (or ventilator-free time) • % patients developing delirium during the ICU stay Adapted from VISICU
  • 41. Managing ICU Agitation • Complexity is daunting • Tempting to use guidelines/bundles blindly – Adapt before you adopt • Caregiver responsibilities – Understand that short AND long-term ICU patient outcomes are affected by therapeutic choice and method of administration • Institution responsibilities – Provide adequate resources to implement systems that guide “best practice” and allow for feedback to caregivers
  • 42. Time to leave….. thanks for your attention fraseg@mmc.org
  • 43. They Do Things Differently Down Under Protocolization of ICU Sedation • NA and European trials = outcomes improve with protocolized sedation • But NOT in Australia! – Why? Is the strategy not beneficial? – Do unique aspects of care impact results? • 1:1 RN to patient ratio Bucknall. Crit Care Med 2008; 36:1444 Elliott. Intensive Care Med 2006; 32:1506 • RNs manage ventilator Fraser. Crit Care Med 2007; 35:635 • ICUs are “closed” • Twice daily multidisciplinary rounding • ANZ care model may impact outcomes more than sedation protocolization
  • 44. How Are Clinical Practice Guidelines Used? Purpose: GUIDE management of complex clinical issues Reality: PRESCRIBE management of complex clinical issues And what’s wrong with that?
  • 45. Intellectual Whiplash Intensive Glucose Control Drotrecogin for Sepsis Factor VIIa for ACTH stim ICH testing Benzo Infusions Steroids for For Long-term Septic Shock Sedation PPI Use for SUP Developing “Fad-Free” Guidelines
  • 46. They Do Things Differently Down Under Protocolization of ICU Sedation • NA and European trials = improved outcomes with protocolized sedation • But NOT in Australia! – Why? Is the strategy not beneficial? – Do unique aspects of care impact results? • 1:1 RN to patient ratio Bucknall. Crit Care Med 2008; 36:1444 Elliott. Intensive Care Med 2006; 32:1506 • RNs manage ventilator Fraser. Crit Care Med 2007; 35:635 • ICUs are “closed” • Twice daily multidisciplinary rounding • ANZ care model may impact outcomes more than sedation protocolization
  • 47. Often Boils Down to Competing Concerns • Breathing vs comfort • Hemodynamic stability vs comfort • Amnesia vs memory formation • Short-term control vs long-term sequelae • Coma vs interactive and comfortable • Side effect profiles: can we accept the risks – Unusual, but deadly (propofol, remi) vs common and manageable (dex) vs easily monitored for and identifiable (opiates)
  • 48. Unique Aspects of ICU Pain • Pain relief usually involves some evasive action – Avoidance response not possible in the ICU • Incredibly common: 71% frequency • Physiologic consequences – Initiates stress response, hemodynamic derangement, hyperglycemia, altered immune function and increases oxygen consumption • Psychological consequences – Anxiety – Delirium – PTSD
  • 49. Discomfort from Typical ICU Procedures Mean Pain Intensity (0-10) N = 6000 Adults Puntillo. Am J Crit Care. 2001;10:238 5 4.5 4 3.5 3 2.5 2 1.5 1 0.5 0 Drain Wound Central Femoral Turning Trach sx removal care line sheath Mean intensity 4.93 4.67 4.42 3.94 2.72 2.65 Less than 25% receive procedural pain management Puntillo. Am J Crit Care 2002;11:415, Payen. Anesthesiology 2007; 106:687
  • 50. Screening Double-Blind Follow-Up up to 96 h Treatment (X - 30 d) 48 h DEX (Optional load; 0.2-1.4 g/kg/h) Randomized 2:1 DEX:MDZ Daily Arousal & CAM-ICU Day 0 Q 4 hr RASS -2 to +1 Nurse Assessment Q Shift ETT MDZ (Optional load; 0.02-0.1 mg/kg/h) Riker. JAMA. 2009; 301:489-99.
  • 51. Dexmedetomidine: Indications and Pharmacology • Alpha-2-adrenergic agonist – Has sedating, anxiolytic, and opiate sparing properties – Permits patient awareness and responsiveness upon stimulation – Not indicated when deep sedation or amnesia is required • Benefits – Does not cause respiratory depression – Decreases sympathetic activity – Reduces shivering – Shorter time on the ventilator and in the ICU with a lower incidence of delirium when compared to benzodiazepine- based sedation Pandharipande. JAMA. 2007;298:2644, Riker. JAMA 2009; 301:489
  • 52. Dexmedetomidine: Concerns • Hypotension and bradycardia – Avoid in patients dependent on sympathetic tone for hemodynamic stability • Excessive sedation • Withdrawal tachycardia/hypertension (theoretical risk)
  • 53. Disadvantages of Benzodiazepines • Oversedation and prolonged duration of mechanical ventilation – Titrate carefully and use daily wake ups
  • 54. Propofol: Indications and Pharmacodynamics • Pharmacology: GABA agonist • Pharmacokinetics/dynamics: onset 1-2 min, duration 10 min • Benefits – Rapid onset & offset • Allows easy dose titration to goal and facilitates daily sedation evaluation • When compared to benzodiazepines, results in shorter time on mechanical ventilation and in the ICU Carson. CCM 2006; 34:1326 – Hypnotic and antiemetic – Can be used for intractable seizures and elevated intracranial pressures
  • 55. Use of Sedative Infusions Project IMPACT database Wunsch. CCM 2009 • 174 U.S. ICUs during 2001-2007 • 50% of >100K mechanically ventilated adult patients received sedative infusions – Most patients received propofol – Pure analgosedation = 10% • A1 still has a long way to go for acceptance – Benzodiazepine infusions still widely used
  • 56. Bundles, Guidelines, and Marginal Data • Sepsis bundle based on “Surviving Sepsis Campaign” (the CPG with the strongest recommendations = abandon futile therapy) – Single center trials • Early goal directed therapy and intensive glucose control – Trials with limited scope • Drotrecogin – Trials that lacked meaningful endpoints • Corticosteroids Not endorsed by IDSA, ATS, ANZICS in part because of the fear that components of the CPG will morph into performance or quality measures. Hicks. Crit Care Resuscitation 2008; 10: 6
  • 57. Dexmedetomidine: ICU Roles • Consider using – When respiratory function is tenuous – When tachycardia and hypertension are present – In conjunction with benzodiazepines for ethanol withdrawal • When is dex probably not indicated – Severe vasodilatory or cardiac shock – If you wouldn’t use beta blockade, you shouldn’t use dex