| 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
|
|
|
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
|
|
|
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
|
|
|
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. |