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
DR.– BHARGAV KIRAN GADDAM
REG. NO: 1601091001 | JUNE/2016O | A PRI L /2019
MD, GENERAL MEDICINE, MGMCRI
GUIDE
DR.M.NARAYANAN
PROFESSOR
DEPARTMENT OF GENERAL MEDICINE, MGMCRI
Co-GUIDE
DR. E. DEYAGARASAN
A SSIST A N T PROFESSOR
DEPARTMENT OF MGMCRI
MAHATMA GANDHI MEDICAL COLLEGE & RESEARCH INSTITUTE

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CANDIDATE
 Candidate Name : DR.BHARGAV KIRAN .G
 Course of Study : MD GENERAL MEDICINE
 University Identity No : 1601091001
 Mobile Phone No : +919866051150
 E-mail Address : kiransmiles21@gmail.com
 Month/Yr of Admission : JUNE2016
 Month/Yr of Examination : APRIL 2019
GUIDES
 GUIDE:DR.M.NARAYANAN
 Professor
 Department of GENERAL MEDICINE
 Contact Number:9444024606
 Email: narayananm@mgmcri.ac.in
 CO GUIDE:
 Dr. E.DEYAGARASAN
 Department of General Medicine
 Contact Number: 9894250451
 Email:drdeyagu@gmail.com

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
PART II – THE PROTOCOL
1 INTRODUCTION
Sepsis is defined as the presence (probable or documented) of infection
together with systemic manifestations
It is the fourth most common admitting diagnosis to the ICU and is the
second leading cause of mortality in the ICU after multi-organ failure.(16)Despite
advances in aggressive management, a diagnosis of sepsis continues to have a high
mortality rate, which increases with sepsis severity from 20.8% in patients with
sepsis and as high as 48.8% in patients with septic shock.
The incidence of severe sepsis in India was 16.45% of all admissions. Mean
age of the population was 58.17 years (SD 18.66), of which 57.71% were male. The
median APACHE II score was 13 (IQR 13 to 14) with predominant (90.93%)
medical admission. Median duration of stay in the ICU for the severe sepsis cohort
who survived was 13 days (IQR 11 to 17). The lung was the predominant source of
sepsis (57.45 %). [4]
Currently there are few reliable therapeutic strategies for the management of
sepsis including empiric antibiotic therapy, aggressive volume repletion, and tight
insulin control. 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

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optimize therapeutic options is critical in order to reduce the ICU mortality
secondary to sepsis.
Recent evidence [7] suggests that serum High density lipoprotein cholesterol
(HDL-C) may be a useful prognostic marker of sepsis given that cholesterol
metabolism has been shown to be markedly influenced by a state of widespread
inflammation secondary to bacteremia. Additional studies (5) 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. These changes have been noted to occur early (within hours) in the
inflammatory cascade associated with sepsis. A reduction in serum cholesterol was
also negatively correlated to clinical outcome
A low HDL-C cholesterol level on day 1 of severe sepsis is significantly
associated with an increase in mortality and adverse clinical outcomes.(2)
Although the reduction in lipid and lipoprotein levels is well known in
critically ill patients (12) their prognostic implications in patients with sepsis remain
controversial. The aim of this study was to investigate the association between HDL-
C and clinical outcome in patients with sepsis
HDL-C value can be used as a biomarker of septicaemia:
 It is easily available
 Cheap
 Septicaemia biomarker due to the wide range of HDL-C normal value
(40 – 60 mg/dl) compared with other biomarkers, also wide range

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from normal value to HDL-C value in septicaemia(from 40 mg/dl to
15 mg/dl).
During septicaemia HDL-C level decreases to low levels accompanied with
hypertriglyceridemia.
The levels of both HDL-C and triglyceride will get increased again when
sepsis is cured until reach to the normal value.

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2 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:
a. To measure HDL-C values in all patients in sepsis.
b. To assess and compare the prognosis and response to treatment in
correlation with values of HDL-C.

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3 REVIEW OF LITERATURE
The word “sepsis” was derived from the ancient Greek for rotten flesh and
putrefaction. Without using the term, the Greek physician Hippocrates (460 to 370
BC) was probably the first to describe the clinical course of septic shock (“when
continuing fever is present, it is dangerous if the outer parts are cold, but the inner
parts are burning hot”)(17).
In 1914, Hugo Schottmüller provided the first scientific definition of sepsis:
“sepsis is a State caused by microbial invasion from a local infectious source into the
bloodstream which leads to signs of systemic illness in remote organs” (18).
According to this definition, bacteremia was a conditio sine qua non to the
diagnosis of sepsis. This notion did not change significantly over the years
SYSTEMIC INFLAMMATORY RESPONSE SYNDROME (SIRS)
The presence of two or more of the following criteria, one of which must be
abnormal temperature or leukocyte count:
• Core
a
temperature of >38.5°C or <36°C
• Tachycardia, defined as a mean heart rate >2 SD above normal for age in the
absence of external stimulus, chronic drugs, or painful stimuli; or otherwise
unexplained persistent elevation over a 0.5- to 4-hour time period or for children
<1 year old: Bradycardia, defined as a mean heart rate <10th percentile for age in
the absence of external vagal stimulus, beta-blocker drugs, or congenital heart
disease;

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• Mean respiratory rate >2 SD above normal for age or mechanical ventilation for an
acute process not related to underlying neuromuscular disease or the receipt of
general anesthesia
• Leukocyte count elevated or depressed for age (not secondary to chemotherapy-
induced leukopenia) or >10% immature neutrophils
SEPSIS
SIRS in the presence of or as a result of suspected or proven infection
SEVERE SEPSIS
Sepsis plus the following: cardiovascular organ dysfunction, acute respiratory
distress syndrome (ARDS), or two or more other organ dysfunctions
SEPTIC SHOCK
Sepsis and cardiovascular organ dysfunction
In 1993 Levine DM et al(19) was the first to explain the protective effect of
HDL-C against bacterial endotoxin. They showed, transgenic mice with high HDL-C
had high levels of endotoxin bound to HDL-C, low levels of cytokine response and
improved survival compared with mice having low HDL-C level.
Hudgins et al,(11) in a study evaluating the systemic inflammatory response in both
septicpatients and healthy volunteers injected with a low dose of endotoxin, found
that there is a major disruption in the normal metabolism of lipids, including lower
levels of circulating HDL-C and the loss of one of the most abundant HDL
apolipoproteins, Apo-A1.(14) Changes in plasma lipids have been demonstrated to

9. 9
occur very early in systemic inflammation, with evidence that HDL-C decreases
within hours of systemic cytokine stimulation,8 suggesting that plasma lipids,
specifically HDL-C and Apo-A1 levels, may have significant promise as a sensitive
prognostic markers of mortality in patients admitted to the ICU with sepsis.,
Windleret al13 suggest that the convenience of total cholesterol is its non-
specificity for any particular disease, which make low serum cholesterol a potential
universal marker of mortality for a spectrum of diagnoses in the ICU.
Shor R et al(20) 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 (OR 17.5 95% CI, 5.2–59.04, P < 0.0001)
Van Leeuwen HJ et al (9) and Dunham CM et al (10) observed finding of
rapidly changing HDL levels in severe sepsis patients,
SH Lee et al (16) concluded from his study that Non-survivors showed
significantly higher SOFA scores than survivors (p = 0.008). Non-survivors had low
levels of cholesterol, TG, HDL, LDL, and apo A-I levels on days 0, 1, 3, and 7.
NareshMonigari*,et al (1) concluded that t here is significant association of
low HDL value on day 1 with mortality. HDL value of 9 mg/dl at admission had
sensitivity of 89% and specificity of 73% predicting the overall mortality in patients
with severe sepsis. 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 favours improvement in
clinical condition and decreasing trend implied worsening of the clinical condition.

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Baseline HDL value correlated with APACHE 2 score in predicting mortality in ICU
Patients
Emerging evidence suggests that serum total cholesterol may be a useful and
superior prognostic marker of mortality for patients admitted to the ICU with sepsis
secondary to infection compared to its CRP and PCT counterparts(6). With larger,
more comprehensive studies, it is likely that evidence will indicate that serum
cholesterol levels will provide ICU clinicians a more sensitive screening tool for
identifying those patients at highest risk for morbidity and mortality irrespective to
other underlying comorbidities, whereas CRP may be more useful for monitoring
response to therapy.
Monitoring serum cholesterol levels on hospital admission could provide a
very novel, inexpensive tool that has the potential to start early and aggressive
therapy in patients most at risk for death, thus decreasing the mortality rate
secondary to sepsis.
Understanding the patho-physiology of lipid metabolism in the event of systemic
inflammation also opens the door to additional experimental therapy including the
use of statin medications in septic patients.(6)
4 RESEARCH QUESTION OR HYPOTHESIS
Whether there is correlation between the levels of HDL-C and the severity
and prognosis of sepsis?

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5 SUBJECTS AND METHODS
5.1 STUDY SUBJECTS
The Study Involves HUMANS
5.2 TYPE OF STUDY
Prospective study
5.3 PLACE OF STUDY
MAHATMA GANDHI MEDICAL COLLEGE AND RESEARCH
INSTITUTE AND HOSPITAL
5.4 SELECTION PROCESS
5.4.1 STUDY POPULATION
This study will be conducted in patients who are proven to be in sepsis
according to to International guidelines for management of severe sepsis and septic
shock 2016
5.4.2 VOLUNTEERS RECRUITEMENT PROCESS
NIL

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5.4.3 INCLUSION CRITERIA
 Patients with age greater than 18 years and satisfying the criteria for sepsis
according to International guidelines for management of severe sepsis and
septic shock 2016 [ ]
5.4.4 EXCLUSION CRITERIA
1. Patients on treatment with statins
2. Patients with Chronic liver disease, chronic kidney disease, thyroid
dysfunction, diabetes.
3. Patients with known chronic inflammatory conditions like Human
immunodeficiency virus disease, SLE (Systemic lupus erythematous) and RA
(Rheumatoid arthritis)
4. Patients diagnosed to have malabsorbption disorders
5.4.5 SAMPLING PROCEDURE
Patients admitted with sepsis.
5.4.6 STUDY GROUPS
The number of group is one
5.4.7 SAMPLE SIZE
100
5.5 METHODOLOGY / PROCEDURES:
This study is being conducted in MGMC&RI. 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

13. 13
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
5.5.1 INTERVENTIONS/DRUGS USED
NO
5.5.2 PROCUREMENT OF INVESTIGATIONAL DRUGS, STORAGE,
DISPENSING, ETC.
NIL
5.6 STUDY TERMINATION
After completion period of study [18 months]
6 STUDY VARIABLES
Serial No : Study Variable Statistics
1 Age Quantitative
2 Gender Qualitative
3 Length of ICU stay (days) Quantitative
4 HDL-C levels Quantitative
5 SOFA score Quantitative
6 Liver function tests Quantitative
7 Blood sugar levels Quantitative

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8 Creatinine levels Quantitative
9 Platelet levels Quantitative
10 PaO2/fi02 (mmhg) Quantitative
11 Glasgow coma scale Quantitative
12 Mean arterial pressure Quantitative
13 CRP Quantitative
6.1 DATA COLLECTION
All data will be entered into a Data Collection Proforma Sheet (Appendix 1)
and entered into Excel (MS Excel 2011). Privacy and Confidentiality to be
maintained.
6.2 STATISTICAL METHODS
Mean , Standard Deviation, Pearson Coefficient test

15. 15
7 REFERENCES
[1] NareshMonigari. 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.
(6) Jung-YienChien, MD; Jih-ShuinJerng, Low serum level of high-density
lipoprotein cholesterol is a poor prognostic factor for severe sepsis .Crit Care Med
2005 Vol. 33, No. 8 :1688-1693
[7] Murch O, Collin M, Hinds CJ, Thiemermann C. Lipoproteins in inflammation
and sepsis. I. Basic science. Intensive Care Med. 2007;33:13-24.

16. 16
[8] Wendel M, Paul R, Heller AR. Lipoproteins in inflammation and sepsis. II.
Clinical aspects. Intensive Care Med. 2007;33:25-35.
(9) van Leeuwen HJ, Heezius EC, Dallinga GM, van Strijp JA, Verhoef J, van
Kessel KP. Lipoprotein metabolism in patients with severe sepsis. Critical care
medicine. 2003;31(5):1359-66.
(10) Dunham CM, Fealk MH, Sever WE, 3rd. Following severe injury,
hypocholesterolemia improves with convalescence but persists with organ failure or
onset of infection. Critical care (London, England). 2003; 7(6):R145-53.
11. Hudgins LC, Parker TS, Levine DM, et al. A single intravenous dose of
endotoxin rapidly alters serum lipoproteins and lipid transfer proteins in normal
volunteers. J Lipid Res. 2003;44:1489-1498.
(12)Gordon BR, Parker TS, Levine DM, et al: Low lipid concentrations in critical
illness: Implications for preventing and treating endotoxemia. Crit Care Med 1996;
24:584–589
13. Windler E, Ewers-Grabow U, Thiery J, Walli A, Seidel D,Greten H. The
prognostic value of hypocholesterolemia in hospitalized patients.
ClinInvestig1994;72:939-943
14. Chien JY, Jerng JS, Yu CJ, Yang PC. Low serum level of high-density
lipoprotein cholesterol is a poor prognostic factor for severe sepsis. Crit Care Med.
2005;33:1688-1693.
.

17. 17
(15) Judith A. Guzman-Cottrill .The Systemic Inflammatory Response Syndrome
(SIRS), Sepsis, and Septic Shock
(16) US Department of Health and Human Services, Health Resources and Services
Administration Report to Congress. The Critical Care Workforce: A Study of the
Supply and Demand for Critical Care Physicians. May 2006. Available at
http://bhpr.hrsa.gov/healthworkforce/reports/studycriticalcarephys.pdf
(17) Gruithuisen VPF (ed).1814. Hippocrates des
ZweytenächtemedizinischeSchriften, ins Deutsche übersetzt. Ignaz Josef Lentner,
Munich, Germany.
(18) Schottmueller H. 1914. Wesen und Behandlung der Sepsis. Inn. Med.31:257–
280.
( 19 ) Levine DM, Parker TS, Donnelly TM, Walsh A, Rubin AL. In vivo protection
against endotoxin by plasma high density lipoprotein. Proceedings of the National
Academy of Sciences of the United States of America. 1993;90(24):12040-4.
(20) Shor R, Wainstein J, Oz D, Boaz M, Matas Z, Fux A, et al. Low HDL levels
and the risk of death, sepsis and malignancy. Clinical research in cardiology : official
journal of the German Cardiac Society. 2008;97(4):227-33
8 PRELIMINARY WORK DONE ALREADY
Proforma has been made
9 ETHICAL ISSUES
NIL

18. 18

19. 19
10 INFORMED CONSENT PROCEDURE
The study involves patient admitted in ward of MGMCRI with diagnosed
septicaemia and no radiation is used during the study
Patient will be explained in detail about the study in their own language and
an informed consent will be obtained.
11 QUALITY CONTROL
Name : DR.JAYASINGH
Designation: PROFESSOR ,HOD
DEPARTMENT OF GENERAL MEDICINE , MGMCRI
Telephone No: 919360231933
E-mail:jayasinghavmc@gmail.com
11 SPONSORSHIPS
Not applicable

20. 20
12 INVESTIGATORS DECLARATION
This is to certify that the protocol entitled “STUDY OF SERUM HDL-
CHOLESTEROL LEVELS IN SEPSIS PATIENTS AND ITS PROGNOSTIC
SIGNIFICANCE” was reviewed by us for submission to the SBV Institutional
Ethics Committee and certified that this protocol represents an accurate and complete
description of the proposed research. We have read the ICMR guidelines, ICP-GCP
guidelines/CPCSEA guidelines/and other applicable guidelines and undertake to
ensure that the rights and welfare of the study subjects are protected.
The study will be performed as per the approved protocol only. If any
deviation is warranted, the same will be presented to the ethical committee and
permission will be sought. We assure that the study will be terminated immediately
in case of any unforeseen adverse consequences and we will inform the same to the
ethical committee immediately.

21. 21
INFORMATION SHEET FOR THOSE WHO PLAN TO PARTICIPATE IN
THE RESEARCH PROJECT
NAME OF THE RESEARCH PROJECT:
STUDY OF SERUM HDL – CHOLESTEROL LEVEL SIN SEPSIS
PATIENTS AND ITS PROGNOSTIC SIGNIFICANCE
We welcome you and thank you for having accepted our request to consider whether
you can participate in our study. This sheet contains the details of the study; the
possible risks, discomfort and benefits for the participants are also given.
You can read and understand by yourself; if you wish, we are ready to read and
explain the same to you.
If you do not understand anything or if you want any more details we are ready to
provide the details.
Information to the participants:
What is the purpose of the study?
To evaluate the correlation between septicaemia and high density
Lipoproteins- Cholesterol (HDL-C-) level in Sepsis patients. To further correlate
with prognostic outcome of patients with abnormal HDL- C Levels.
Who / where this study is being conducted?
This study is being conducted by Dr. Bhargav Kiran Gaddam Post Graduate
Medical Student belonging to General Medicine under the guidance of Dr. M.
Narayanan

22. 22
Why I am being considered as one of the participant?
Since you have been diagnosed to be in sepsis therefore you are included in
the study.
Should I definitely have to take part in this study?
No. If you do not wish to participate you will not be included in this study.
Also you will continue to get the medical treatment without any prejudice.
If I am participating in this study, what are my responsibilities?
You should provide us with permission to access your case sheet and collect
data from it.
Are there any benefits for me / public?
Yes. If the results of the study are found to be favourable, then this method
can be used as prognostic marker of sepsis.
Will there be any discomfort / risks to me?
No there will not be any risks or discomfort to you.
Will I be paid for the study?
No. You will not be paid.
Will my participating in this study, my personal details will be kept
confidentially?
Yes, confidentiality will be maintained.
Will I be informed of this study’s results and findings?
Yes, if you want you can get the details from us.
Can I withdraw from this study at any time during the study period?

23. 23
Yes. You can withdraw at any time during the study period.

24. 24
MAHATMA GANDHI MEDICAL COLLEGE AND RESEARCH
INSTITUTE, PUDUCHERRY
FORM FOR GETTING INFORMED CONSENT FOR THOSE
PARTICIPATING IN THE RESEARCH PROJECT
NAME OF THE RESEARCH PROJECT: STUDY OF SERUM HDL –
CHOLESTEROL LEVEL SIN SEPSIS PATIENTS AND ITS
PROGNOSTIC SIGNIFICANCE
I _______________________ have been informed about the details of the study in
own language.
I have understood the details about the study.
I know the possible risks and benefits for me, by taking part in the study.
I understand that I can withdraw from the study at any point of time and even then, I
will continue to get the medical treatment as usual.
I understand that I will not get any payment for taking part in this study.
I will not object if the results of this study is getting published in any medical
journals, provided my personal identity is not reviewed.
I know what I am suppose to do by taking part in this study and I assure that I will
give my full co-operation for this study.
Signature/Thumb impression of the participant
(Name/Address)
__________________________________
__________________________________
__________________________________
Signature/Thumb impression of the witness (Name/Address)
____________________________________________________________________
__________________________________
Name & Signature of the investigator
__________________________________
__________________________________

25. 25
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