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CTRI Number  CTRI/2025/03/082150 [Registered on: 11/03/2025] Trial Registered Prospectively
Last Modified On: 24/02/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Diagnostic 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing ICU and Ward Use of Terlipressin for particapants with kidney injury in liver disease.Evaluating Breathing, Lung Health, and Treatment Response using lung scan and chest xray. 
Scientific Title of Study   An Open Label, Pilot, Randomized Controlled Trial of terlipressin in icu Versus Terlipressin in ward in the Treatment of Type 1 Hepatorenal Syndrome through assessment of respiratory parameters,lung ultrasound scores and RALES score in patients and Predictors of Response. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vedaghosh Amara  
Designation  Consultant Critical Care Medicine  
Affiliation  AIG Hospitals 
Address  Department of Critical Care,3rd floor, Tower A, Mindspace road, Gachibowli, Hyderabad
Department of Critical Care,3rd floor, Tower A, Mindspace road, Gachibowli, Hyderabad
Hyderabad
TELANGANA
500032
India 
Phone  9985087798  
Fax    
Email  vedaghosh@gmail.com   
 
Details of Contact Person
Scientific Query
 
Name  Vedaghosh Amara  
Designation  Consultant Critical Care Medicine  
Affiliation  AIG Hospitals 
Address  Department of Critical Care,3rd floor, Tower A, Mindspace road, Gachibowli, Hyderabad

Hyderabad
TELANGANA
500032
India 
Phone  9985087798  
Fax    
Email  vedaghosh@gmail.com   
 
Details of Contact Person
Public Query
 
Name  Vedaghosh Amara  
Designation  Consultant Critical Care Medicine  
Affiliation  AIG Hospitals 
Address  Department of Critical Care,3rd floor, Tower A, Mindspace road, Gachibowli, Hyderabad

Hyderabad
TELANGANA
500032
India 
Phone  9985087798  
Fax    
Email  vedaghosh@gmail.com   
 
Source of Monetary or Material Support  
AIG Hospitals 
 
Primary Sponsor  
Name  AIG Hospitals 
Address  Department of Critical Care,3rd Floor, Main Block, Mindspace road, Gachibowli. Hyderabad TELANGANA 500032 India  
Type of Sponsor  Private hospital/clinic 
 
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 
Vedaghosh Amara   AIG Hospitals  Department of Critical Care,3rd Floor,Main Block,Mindspace road,Gachibowli. Hyderabad
Hyderabad
TELANGANA 
9985087798

vedaghosh@gmail.com  
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Asian Institute of Gastroenterology  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K746||Other and unspecified cirrhosis ofliver,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intravenous Terlipressin 1 mg q12h and Albumin 20g in 100ml once a day until clinical improvement or maximum of 14 days   using ultrasound and chest xray to see worsening or improvement of lung parameters. 
Comparator Agent  Intravenous Terlipressin 1 mg q12h and Albumin 20g in 100ml once a day until clinical improvement or maximum of 14 days in ward   using chest xay to see for worsening or improvement of lung parameters in patients of hepatorenal syndrome. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients admitted to the critical care unit diagnosed as hepatorenal syndrome on treatment with terlipressin plus albumin.  
 
ExclusionCriteria 
Details  Patient not willing for ultrasound.
Improvement in renal function after central blood volume expansion.
History of infection within the past week, excluding spontaneous bacterial peritonitis.
History of coronary artery disease, obstructive cardiomyopathy, ventricular arrhythmia, or obliterative arterial disease of the limbs.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess respiratory parameters, side effect profile and venous congestion in patients with hepatorenal syndrome being treated with terlipressin plus albumin in intensive care vs ward through ultrasound and rales score and its association with various outcomes in intensive care stay.  Day 1-15 
 
Secondary Outcome  
Outcome  TimePoints 
To determine how measurement of venous congestion and assessment of respiratory parameters using ultrasound and rales score in patients of hepatorenal syndrome on terlipressin plus albumin helps in evaluation of fluid overload and its impact on clinical, demographic and biochemical variables in intensive care vs ward settings.  Day 1-15 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   15/03/2025 
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="11"
Days="30" 
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 - NO
Brief Summary  

Hepatorenal syndrome (HRS) is kidney injury caused by renal vasoconstriction due to systemic and splanchnic vasodilation in advanced cirrhosis. Albumin therapy increases central blood volume and cardiac index without affecting central venous pressure, helping maintain circulation and renal perfusion. Ideal HRS treatment would selectively vasodilate renal circulation without affecting other vascular beds. Both terlipressin and noradrenaline are effective vasoconstrictors. Unlike norepinephrine, terlipressin can be given peripherally and outside the ICU but may cause severe respiratory failure in patients with volume overload, acute-on-chronic liver failure (grade 3), or pre-existing respiratory compromise. Rapid albumin administration may worsen hypervolemic states like heart failure, CKD, and liver disease. Point-of-care ultrasound (POCUS) enables bedside physiological assessment. Lung ultrasound scores and venous excess scores help correlate fluid overload with organ function, preventing complications and improving outcomes. POCUS aids fluid management in sepsis and hypovolemia and supports clinical decisions regarding diuretics or inotropic therapy in AKI. The Radiographic Assessment of Lung Edema (RALE) score quantifies alveolar opacities on chest X-rays and independently predicts ARDS severity and outcomes. As terlipressin can be administered peripherally in wards, we aim to compare its side effect profile in ICU vs. ward settings. In the ICU, lung ultrasound is performed daily alongside RALE scoring, whereas it is less frequently used in wards. This study seeks to correlate lung ultrasound and RALE scores in predicting fluid overload in HRS patients receiving terlipressin and albumin in ICU vs. ward settings.

 
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