| 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
|
|
|
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
|
|
|
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. |