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CTRI Number  CTRI/2025/02/080614 [Registered on: 14/02/2025] Trial Registered Prospectively
Last Modified On: 09/02/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   comparision of lung parameters using ultrasound and chest xray in patients recieving terlipressin and noradrenaline in participants with kidney injury in liver disease patients. 
Scientific Title of Study   Comparison of Terlipressin vs Noradrenaline Through Assessment of Respiratory Parameters, Lung Ultrasound Scores, and RALES Score in Patients With Hepatorenal Syndrome – A Comparative Randomized Controlled 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  Vedaghosh Amara  
Designation  Consultant Critical Care Medicine  
Affiliation  AIG Hospitals 
Address  Department of Critical Care,3rd floor, Tower A, Mindspace road, Gachibowli. Hyderabad TELANGANA 500032 India

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 TELANGANA 500032 India

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 TELANGANA 500032 India

Hyderabad
TELANGANA
500032
India 
Phone  9985087798  
Fax    
Email  vedaghosh@gmail.com   
 
Source of Monetary or Material Support  
Aig Hospitals,Mindspace road,Gachibowli,Hyderabad,Telangana-500032  
 
Primary Sponsor  
Name  AIG Hospitals 
Address  Aig Hospitals,Mindspace road,Gachibowli,Hyderabad,Telangana-500032  
Type of Sponsor  Other [Center of study conduct] 
 
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  Tower A, 3rd floor ICU, Mindspace Rd, P Janardhan Reddy Nagar, Gachibowli, Hyderabad, Telangana 500032
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 
Comparator Agent  Noradrenaline  minimum dose of 0.02MCG/KG/MIN untill clinical improvement or maximum of 14 days. 
Intervention  Terlipressin + Albumin   Terlipressin 1 mg q12h and Albumin 20g in 100ml once a day until clinical improvement or maximum of 14 days 
 
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 or noradrenaline plus albumin.  
 
ExclusionCriteria 
Details  Patients not willing for ultrasound examination.
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 and venous congestion in patients with hepatorenal syndrome being treated with noradrenaline and terlipressin plus albumin through ultrasound and rales score and its association with various outcomes in intensive care stay.  DAY 1 TO 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 or noradrenaline plus albumin helps in evaluation of fluid overload and its impact
on clinical, demographic and biochemical variables. 
Day 1 to 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   Phase 4 
Date of First Enrollment (India)   25/02/2025 
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 a kidney injury caused by renal vasoconstriction due to systemic and splanchnic arterial vasodilation in advanced cirrhosis. Goal-directed therapy with albumin increases blood volume and cardiac output without affecting central venous pressure, helping maintain circulation and kidney perfusion. The ideal HRS treatment would selectively dilate renal blood vessels without affecting other circulations, especially splanchnic vessels. Both terlipressin and noradrenaline are effective vasoconstrictors for HRS. However, terlipressin may cause severe respiratory failure in volume overload, grade 3 acute-on-chronic liver failure, or pre-existing respiratory compromise. Rapid albumin administration can also worsen conditions like congestive heart failure, chronic kidney disease, and chronic liver disease. Point-of-care ultrasound (POCUS) enables bedside assessment of fluid status and organ function, helping prevent complications and guide treatment decisions. Lung ultrasound and venous excess scores can indicate fluid overload, aiding in diuretic or inotropic adjustments. The RALE score assesses lung edema severity on chest X-rays and predicts ARDS severity and outcomes. This study aims to correlate lung ultrasound and RALE scores with fluid overload in HRS patients receiving noradrenaline or terlipressin with albumin.

 
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