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CTRI Number  CTRI/2025/07/091234 [Registered on: 21/07/2025] Trial Registered Prospectively
Last Modified On: 21/07/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   To understand the changes in lipid profile in severe infections  
Scientific Title of Study   Lipid derangement in sepsis and non-infective systematic inflammatory response syndrome 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ruchi Gupta 
Designation  Consultant 
Affiliation  Holy Family Hospital 
Address  Department of Critical Care Medicine Holy Family Hospital Okhla Road, New Delhi

South
DELHI
110025
India 
Phone  9910695602  
Fax    
Email  ruchi_gupta.mamc@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Sahil Kataria 
Designation  Consultant 
Affiliation  Holy Family Hospital 
Address  Department of Critical Care Medicine Holy Family Hospital Okhla Road, New Delhi

South
DELHI
110025
India 
Phone  9910700323  
Fax    
Email  sahilkataria2612@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sumit Ray 
Designation  Medical Director and Head of Department 
Affiliation  Holy Family Hospital 
Address  Department of Critical Care Medicine Holy Family Hospital Okhla Road, New Delhi

South
DELHI
110025
India 
Phone  9810614433  
Fax    
Email  drsray67@yahoo.co.in  
 
Source of Monetary or Material Support  
Holy Family Hospital Okhla Road New Delhi-110025 India 
 
Primary Sponsor  
Name  Dr Ruchi Gupta 
Address  Department of Critical Care Medicine Holy Family Hospital Okhla Road New Delhi-110025 India 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ruchi Gupta  Holy Family Hospital  Department of Critical Care Medicine Holy Family Hospital Okhla Road, New Delhi
South
DELHI 		 9910695602

ruchi_gupta.mamc@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Holy Family Hospital Institute Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: A419||Sepsis, unspecified organism,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  Patients more than 16 and less than 85 years of age admitted with SIRS in intensive care unit will be included within 24 hours of admission.
Sepsis will be defined based on Sepsis 3.0 definition and either clinically, radiologically or microbiological evidence of bacterial infection.
Non infective SIRS will be defined by Acute pancreatitis or trauma presenting within 48hrs of onset.
 
 
ExclusionCriteria 
Details  1.Refusal to give consent
2.Patients on Lipid lowering drugs
3.Severe Malnourishment: BMI less than18 or more than30
4.Uncontrolled diabetes mellitus (HBA1c more than 8)
• Known eating disorders.
• Known Metabolic Syndromes
• Post operative patients
Non specific causes of SIRS
Non bacterial causes of infection like viral, fungal protozoal etc.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the lipid profile in patients with sepsis and non-infective Systemic inflammatory response syndrome patients like acute pancreatitis and early trauma.   Day 0 and 3 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the correlation between lipid profiles and 30-day mortality in patients with sepsis   Day 0 and 3 
To assess the association of the lipid profile in sepsis with severity of illness using APACHE II and Sequential Organ Failure Assessment (SOFA) score.   day 0 and 3 
To find the trend of the lipid profile over time (at admission and the 3rd day) in patients with sepsis admitted to the ICU.   Day 0 and 3 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/08/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

This prospective observational study will be conducted over 1year (16th july 2025 to 15july 2026). After approval of the local ethical committee and obtaining informed written consent, all patients > 16 years of age admitted to the intensive care unit of a tertiary teaching hospital with suspicion of sepsis will be included in the study. The demographic characteristics (age, sex), initial vitals, initial lab investigations, diagnosis, The Acute Physiology and Chronic Health Evaluation II (APACHE II) and Sepsis-related Organ Failure Assessment (SOFA) severity scores, and clinical data will be collected prospectively for each patient. 

Serum lipid profile [triglyceride (TG), cholesterol, low-density lipoprotein (LDL), VLDL and high density lipoprotein (HDL)] measured by enzymatic method at admission and on day three will be recorded for each patient. ICU and in-hospital mortality at 30days, length of stay in the ICU and the hospital, renal replacement therapy and vasopressor use, and SOFA score at admission at 48 hours will be collected. The changes in lipid profile between sepsis and non infective SIRS; and correlation of lipid profile with severity off illness and mortality will be noted.

 
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