Dr.Bhargav kiran general medicine dissertation protocol submission-to-the-sbv-mgmcri-ethics-committee-2016-2017

1. STUDY OF SERUM HDL-CHOLESTEROL LEVELS IN
SEPSIS PATIENTS AND ITS PROGNOSTIC SIGNIFICANCE
1
INVESTIGATOR
DR.– BHARGAV KIRAN GADDAM
REG. NO: 1601091001
MD, GENERAL MEDICINE, MGMCRI.
GUIDE :
DR. M.NARAYANAN
PROFESSOR
DEPARTMENT OF GENERAL MEDICINE , MGMC & RI
CO-GUIDE
DR. E.DEYAGARASAN
ASSISTANT PROFESSOR
DEPARTMENT OF GENERAL MEDICINE , MGMC & RI

2. INTRODUCTION
• Sepsis is defined as the presence (probable or documented) of infection together with systemic
manifestations
• It is the second leading cause of mortality in the ICU after multi-organ failure.
• Given that the reversibility of severe sepsis is poor, the need for an “Early Prognostic Marker” to
identify those at highest risk for mortality in order to optimize therapeutic options is critical
there by to reduce the ICU mortality secondary to sepsis.
• Recent evidence shows that serum High density lipoprotein cholesterol (HDL-C) may be a
useful prognostic marker of sepsis .
• Additional studies have demonstrated that patients diagnosed with severe sepsis in the ICU
have a measured decrease in circulating level of lipoproteins and an increase in triglycerides
independent of comorbidities.

3. REVIEW OF LITERATURE
Naresh Monigari et al ( July 2015 : Manipal)(1) concluded that there is significant association
of low HDL value on day 1 with mortality.
Risk of death in patients with day 1 HDL value <10mg/dl is 7.01 times the risk of death in patients with
day 1 HDL value ≥10mg/dl .
Trend of HDL correlated with clinical outcome of patients. Raising trend favors improvement in clinical
condition and decreasing trend implied worsening of the clinical condition.
SH Lee et al (2015) (3) concluded from his study that Non-survivors showed significantly higher
SOFA scores than survivors .Non-survivors had low levels of HDL, on days 0, 1, 3, and 7.
Shor R et al (2008) retrospective analysis of 204 patients showed low HDL (≤20 mg/dl) was
associated with a 17.5-fold increase in odds for death compared to HDL ≥ 65 mg/dl

4. AIMS AND OBJECTIVES
• Aim: To evaluate the correlation between septicemia and high
density Lipoproteins–Cholesterol (HDL-C-) level in Sepsis patients. To
further correlate with prognostic outcome of patients with abnormal
HDL-C levels.
• Objectives:
• To measure HDL-C values in all patients in sepsis.
• To assess and compare the prognosis and response to treatment
in correlation with values of HDL-C.

5. INCLUSION CRITERIA
Patients with age greater than 18 years and satisfying the criteria
for Sepsis.
EXCLUSION CRITERIA
• Patients on treatment with statins
• Patients with Chronic liver disease, chronic kidney disease, thyroid
dysfunction, diabetes.
• Patients with known chronic inflammatory conditions like Human
immunodeficiency virus disease, SLE (Systemic lupus erythematous)
and RA (Rheumatoid arthritis)
• Patients diagnosed to have malabsorption disorders.

6. METHODOLOGY
• This study is being conducted in MGMC&RI.
• The study period is from November 2016 to march 2018.
• Those patients diagnosed to be in Sepsis will be the study participants.
• Whenever patient is diagnosed to be in sepsis, those patients will be
contacted immediately.
• Details of the study will be explained in detail. Permission is sought in the
form of written consent and the study is conducted.
• After ethical committee approval all the patients diagnosed to have sepsis in
High dependency units/wards of Mahatma Gandhi Medical College and
research institute will be recruited for the study.
• Blood samples from each patient will be taken for HDL-C-cholesterol levels,
creatinine, bilirubin levels, and platelet levels at the time of admission and on
the day 5 after admission and SOFA scores will be calculated accordingly on
day of admission and day 5 and assessed accordingly.

7. SAMPLE SIZE:
 After going through the past records I selected the number of patients to be included in the study would be
100.
STUDY GROUPS: Number of groups: ONE
TYPE OF STUDY:
 Hospital based observation-
cross sectional study.
STATISTICS: Study Variables :
ETHICAL ISSUES
 Patient will be included in the study
after getting Informed consent.
 All the investigations and management
For vulnerable patients are done according to
existing guidelines and for Re-stratification
the Prognosis of the patient HDL-C levels are
Estimated and assessed routinely in treatment
(which are availed not at the expense of patients.)
SERIAL NO :
STUDY VARIABLE MEASUREMENT STATISTICS
1 AGE QUANTITATIVE MEAN / SD
2 GENDER QUALITATIVE PERCENTAGE
3 LENGTH OF ICU STAY (DAYS) QUANTITATIVE MEAN / SD
4 HDL-C LEVELS QUANTITATIVE MEAN / SD
5 SOFA SCORE QUANTITATIVE MEAN / SD
6 LIVER FUNCTION TESTS QUANTITATIVE MEAN /SD
7 BLOOD SUGAR LEVELS QUANTITATIVE MEAN / SD
8 CREATININE LEVELS QUANTITATIVE MEAN/ SD
9 PLATELET LEVELS QUANTITATIVE MEAN / SD
10 PAO2/FI02 (MMHG) QUANTITATIVE MEAN / SD
11 GLASGOW COMA SCALE QUANTITATIVE MEAN / SD
12 MEAN ARTERIAL PRESSURE QUANTITATIVE MEAN/ SD
13 CRP QUANTITATIVE MEAN / SD

8. REFERENCES
[1] Naresh Monigari. Study of Serum HDL Levels in Severe Sepsis Patients in
Medical Intensive Care Unit. International Journal of Scientific and Research
Publications, Volume 5, Issue 7, July 2015
(2) Thomas, Whitney, "Serum cholesterol: A Superior Prognostic Marker of
Sepsis Mortality in the ICU Compared to Procalcitonin or Creactive Protein"
(2015). School of Physician Assistant Studies. Paper528
(3) Lee et al. Intensive Care Medicine Experimental 2015, 3(Suppl 1):A226
(4) Todi S, Chatterjee S, Sahu S, Bhattacharyya M. Epidemiology of severe
sepsis in India: an update. Critical Care. 2010;14 (Suppl 1):P382
[5] Herzum I, Renz H. Inflammatory markers in SIRS, sepsis and septic shock.
Curr Med Chem. 2008;15:581-587.