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CTRI Number  CTRI/2025/12/099513 [Registered on: 19/12/2025] Trial Registered Prospectively
Last Modified On: 18/12/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Assessing the response to treatment in the form of fluid bolus by using internal jugular vein distensibility index in long term liver disease patients with shock on ventilator A prospective observational study 
Scientific Title of Study   Assessment of volume responsiveness using internal jugular vein distensibility index(IJV DI) in mechanically ventilated patients with decompensated chronic liver disease(DCLD) and septic shock 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 Sonam Satija 
Designation  Assistant professor 
Affiliation  Institute of liver and biliary sciences 
Address  Institute of liver and biliary sciences D1 vasant kunj new delhi

New Delhi
DELHI
110070
India 
Phone  8130657296  
Fax    
Email  sonamravigupta1@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Swathi M R 
Designation  Senior resident 
Affiliation  Institute of liver and biliary sciences 
Address  Institute of liver and biliary sciences D1 vasant kunj new delhi

New Delhi
DELHI
110070
India 
Phone  9611889494  
Fax    
Email  swathimr777@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Swathi M R 
Designation  Senior resident 
Affiliation  Institute of liver and biliary sciences 
Address  Institute of liver and biliary sciences D1 vasant kunj new delhi

New Delhi
DELHI
110070
India 
Phone  9611889494  
Fax    
Email  swathimr777@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  Institute of liver and biliary sciences 
Address  D1 vasant kunj new delhi 110070 Delhi India 
Type of Sponsor  Research institution and hospital 
 
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 Sonam satija  Institute of liver and biliary sciences  Department of Anaesthesiology Liver coma ICU ILBS D 1 vasanth kunj new delhi 110070
New Delhi
DELHI 		 8130657296

sonamravigupta1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Communication of decision of institutional ethics committee/ institutional review board  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 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Diagnosis of decompensated chronic liver disease
Septic shock as per sepsis 3 definition
On controlled mechanical ventilation
IJV accessible for ultrasound evaluation
 
 
ExclusionCriteria 
Details  ARDS
Cardiac arrhythmias
Central vein thrombosis
Pregnancy
Poor echocardiographic windows
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the diagnostic accuracy of internal jugular vein distensibility index in predicting volume responsiveness in patients with decompensated chronic liver disease and septic shock  Baseline and after volume resuscitation 
 
Secondary Outcome  
Outcome  TimePoints 
To correlate IJV distensibility index with stroke volume changes measured using LVOT VTI after a standardized fluid challenge  Baseline & after fluid challenge 
To determine the optimal cut off value of IJV distensibility index for predicting fluid responsiveness  baseline & after fluid challenge 
To assess the influence of ventilation settings on IJV DI performance  baseline  
To assess the influence of intra abdominal pressure grade on predictive performance of IJV DI  baseline 
To evaluate clinical associations of baseline IJV DI & responder status with vasopressor free days at 7 days ICU & hospital length of stay need for RRT & 28day mortality  baseline 7 days 28 days 
to assess feasibility metrics including proportion of patients with adequate IJV imaging & average time required for IJV assessment  at the end of study 
to determine the relationship between baseline IJV distensibility index & lactate clearance in the first 6 hours after resuscitation  baseline & 6 hours 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   01/01/2026 
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
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  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 - Proposals should be directed to [sonamravigupta1@gmail.com].

  6. For how long will this data be available start date provided 07-01-2027 and end date provided 07-01-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   Decompensated chronic liver disease refers to cirrhosis complications such as ascitis  jaundice hepatic encephalopathy variceal bleed They are often prone for septic shock because of the associated immune dysfunction bacterial translocation from gut poor nutrition etc Fluid management can be challenging because of underlying splanchnic vasodilation hypoalbuminemia causing effective low circulatory volume risk of hepatorenal syndrome Hence fluid management in these cases should always be guided by dynamic measures than static measures IJV DI is one such ultrasound based dynamic measure which is repeatable non invasive Since traditional measures like inferior venacava distensibility is unreliable in these patients due to increased intra abdominal pressure our study aims to evaluate the role and ability of IJV distensibility index in predicting the fluid responsiveness in this population  
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