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CTRI Number  CTRI/2025/08/093276 [Registered on: 19/08/2025] Trial Registered Prospectively
Last Modified On: 19/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Relation of triglyceride glucose index with patients of sepsis 
Scientific Title of Study   Predictive Value of Triglyceride-Glucose index for Disease Severity and Mortality in Icu patients with Sepsis 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Akshat Mehrotra  
Designation  Junior resident  
Affiliation  Kasturba hospital manipal 
Address  NIH block c,Kasturba hospital manipal,near tiger circle,Madhav nagar

Udupi
KARNATAKA
576104
India 
Phone  7055260555  
Fax    
Email  mehrotraakshath09@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Chandrashekar U K 
Designation  HEAD OF UNIT AND PROFESSOR 
Affiliation  Kasturba hospital manipal 
Address  Kasturba hospital manipal,near tiger circle,Madhav nagar

Udupi
KARNATAKA
576104
India 
Phone  9845163448  
Fax    
Email  shekar.uk@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Akshat Mehrotra  
Designation  Junior resident  
Affiliation  Kasturba hospital manipal 
Address  NIH block c,Kasturba hospital manipal,near tiger circle,Madhav nagar

Udupi
KARNATAKA
576104
India 
Phone  7055260555  
Fax    
Email  mehrotraakshath09@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Akshat Mehrotra 
Address  NIH block c,kasturba hospital manipal,near tiger circle,madhav nagar manipal,karnataka,india pin code 576104 
Type of Sponsor  Other [] 
 
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 
DrAKSHAT MEHROTRA  KASTURBA MEDICAL COLLEGE  GENERAL MEDICINE DEPARTMENT,KMC MANIPAL,NEAR TIGER CIRCLE,MADHAV NAGARUDUPI,KARNATAKA
Udupi
KARNATAKA 		 7055260555

mehrotraakshath09@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE-2  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: A00-B99||Certain infectious and parasitic diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Adult patients more 18 year old admitted to the intensive care unit with diagnosis of sepsis, defined according to sepsis -3 criteria(suspected or confirmed infection with sofa sequential organ failure assessment (SOFA)score of more than3) 
 
ExclusionCriteria 
Details  patient with missing triglyceride or glucose values within 24 hours of ICU admission.icu stay within 24 hours(early discharge,or death within one day) patient with decompensated liver disease or end stage kidney disease requiring dialysis,patient receiving lipid lowering drugs, and pregnant patients 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Survived or non-survived (In-hospital mortality)  7 days 
 
Secondary Outcome  
Outcome  TimePoints 
1)Duration of hospitalization in days
2)Need for mechanical ventilation
3)Need for vasopressors 		 7 days 
 
Target Sample Size   Total Sample Size="135"
Sample Size from India="135" 
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)   30/08/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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   Baseline patient characteristics including demographic data (age, gender), presence of comorbidities, ICU admission diagnosis, source of infection, vital signs, duration of intensive care unit (ICU) stay, need for mechanical ventilation, will be noted using a predefined format.Vital signs, scoring system results, and laboratory parameters will be recorded within the first 24 hours following admission to the ICU.Disease Severity Scores such as Sequential Organ Failure Assessment (SOFA) Score, and Acute Physiology and Chronic Health Evaluation (APACHE-II) Score will be noted at ICUadmission.Routine laboratory findings, including complete blood count, kidney function tests, liver function tests, serum electrolytes, coagulation parameters, and arterial blood gas analysis, performed within 24 hours of ICU admission will be recorded.Metabolic markers such as triglycerides (mg/dL), fasting glucose (mg/dL), and the TyG index within the same timeframe will observed and will be noted.All patients admitted to the hospital with sepsis will be followed up for the clinical outcome. Only one admission of the patient during the study period will be considered. 
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