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CTRI Number  CTRI/2026/01/101723 [Registered on: 21/01/2026] Trial Registered Prospectively
Last Modified On: 20/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Combination of serum sodium and lactate as a better predictor of mortality in critically ill patients with decompensated Liver Disease admitted in ICU ; A prospective observational study  
Scientific Title of Study   Combination of serum sodium and lactate as a better predictor of mortality in critically ill patients with decompensated Liver Disease admitted in ICU ; A prospective observational study 
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 Prithvi Raj Gauri 
Designation  DrNB Resident Critical Care Medicine 
Affiliation  B L Kapur MAX Superspeciality Hospital New Delhi 
Address  Department Of Critical Care Medicine B L Kapur MAX Superspeciality Hospital Pusa Road Radha Soami Satsang Rajinder Nagar New Delhi
B L Kapur MAX Superspeciality Hospital Pusa Road Radha Soami Satsang Rajinder Nagar New Delhi 110005
Central
DELHI
110005
India 
Phone  8368080121  
Fax    
Email  prithvirajgauri07@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pradyut Bag 
Designation  DIRECTOR 
Affiliation  B L Kapur MAX Superspeciality Hospital New Delhi 
Address  Department Of Critical Care Medicine B L Kapur Max Superspeciality Hospital Pusa Road Radha Soami Satsang Rajinder Nsgar New Delhi
Department Of Critical Care Medicine B L Kapur Max Superspeciality Hospital Pusa Road Radha Soami Satsang Rajinder Nsgar New Delhi
Central
DELHI
110005
India 
Phone  9999879975  
Fax    
Email  drpbag@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Prithvi Raj Gauri 
Designation  DrNB Resident Critical Care Medicine 
Affiliation  B L Kapur MAX Superspeciality Hospital New Delhi 
Address  Department Of Critical Care Medicine B L Kapur MAX Superspeciality Hospital Pusa Road Radha Soami Satsang Rajinder Nagar New Delhi
Department Of Critical Care Medicine B L Kapur MAX Superspeciality Hospital Pusa Road Radha Soami Satsang Rajinder Nagar New Delhi
Central
DELHI
110005
India 
Phone  8368080121  
Fax    
Email  prithvirajgauri07@gmail.com  
 
Source of Monetary or Material Support  
B L Kapur MAX Superspeciality Hospital Pusa Road Radha Soami Satsang Rajinder Nagar Delhi 110005 
 
Primary Sponsor  
Name  NIL 
Address  NA 
Type of Sponsor  Other [NA] 
 
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 Prithvi Raj Gauri  B L Kapur Max Superspeciality Hospital Delhi  Department Of Critical Care Medicine B L Kapur MAX Superspeciality Hospital Pusa Road Radha Soami Satsang Rajendra Place New Delhi 110005
Central
DELHI 		 8368080121

prithvirajgauri07@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr B L Kapur Memorial Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K740||Hepatic fibrosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Patients classified on basis of standardised criteria for decompensated liver disease diagnosed by standardised guidelinebased on history physical examination lab investigation and radiological imaging
Age more than 18 years
Patients with ICU stay more than 24 hours 
 
ExclusionCriteria 
Details  1 Patients with advanced cardiac failure decompensated heart failure cardiogenic shock
2 Patients with known psychiatric disorders
3 Patients admitted for elective procedures
4 Patient in hypoxia
5 Patients on drugs causing an increase of serum lactate levels
6 Patients with advanced malignancy
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
MORTALITY   4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Length of ICU and Hospital stay   Hospital Discharge /Mortality 
Incidence of hospital acquired Infections   Hospital Discharge / Mortality 
 
Target Sample Size   Total Sample Size="160"
Sample Size from India="160" 
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)   02/02/2026 
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 Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  data can be accessed as an Excel file by e-mailing to prithvirajgauri07@gmail.com

  6. For how long will this data be available start date provided 01-11-2026 and end date provided 01-10-2029?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Liver Cirrhosis is a common chronic disease that is also a leading cause of death among non malignant diseases.Decompensated cirrhosis also called Decompendsated Liver disease is defined as acute deterioration of liver function in a patinet with cirrhosis and is characterised by jaundice , ascites , hepatic encephalopathy , hepatorenal syndrome , or variceal haemorrhage .Patients with Decompensated liver disease (DCLD) with biochemical abnormalities often need to be admitted in intensive care units. Low serum sodium levels and high serum lactate levels are often common biochemical abnormality found in them . Traditionally, prognosis of DCLD has been determined by the Child-Turcotte-Pugh (CTP) and Model for End-Stage Liver Disease (MELD) scoring systems (6). MELD and CTP scores have been known to have their own limitations. Studies which have considered sodium and lactate together as prognostic marker for inpatient mortality in DCLD are limited. Serum sodium and lactate are a readily available, reproducible, and objective laboratory tests.  Thus prognostic value of both sodium and Lactate value taken together into consideration needed further investigation . We plan to perform a prospective observational study to explore the impact of serum sodium, lactate or a combination of serum sodium and lactate on 28-day mortality in patients with decompensated liver disease admitted to ICU of Dr B L Kapur Hospital New Delhi. 
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