Efficacy of early terlipressin (drug) in ACLF (Liver Disease)

Not Applicable

Completed

• Conditions: Health Condition 1: K769- Liver disease, unspecified

• Registration Number: CTRI/2020/06/026006
• Lead Sponsor: Institute of Liver and Biliary Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-06-10
• Last Update Posted: 1 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 70

Inclusion Criteria

1) Age 18-65 years

2) ACLF as per APASL criteria

3) AKI at admission as defined by ICA-AKI criteria

4) AKI stage 2/3 at 12 hour of admission

Exclusion Criteria

At Admission:

1) Age <18 years

2) Patients on renal replacement therapy (RRT)

3) Post renal or liver transplantation

4) History of CAD, ischemic cardiomyopathy, PVD, ventricular arrhythmia

5) Decompensated cirrhosis not fulfilling ACLF criteria

6) Cirrhotics with AKI managed as outpatients

7) Grade III/IV HE or Shock requiring inotropes or patients on mechanical ventilator at time of randomization

9) In-hospital new AKI

10) Active urinary sediments - 2+ albumin or above, dysmorphic RBCs

11) Known CKD, obstructive uropathy

12) Lack of informed consent

13) Prior intolerance or S/E to Terlipressin or albumin

At 12 Hour before randomization:

•Regression of AKI ( >0.3 mg/dl) above baseline after IV albumin (20% 40 gm) + IV Crystalloids 500 ml therapy for 12 hours

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Acute Kidney Injury reversal by day 7 in both groupsTimepoint: Day 7

Secondary Outcome Measures

Name	Time	Method
Adverse Events in both groupsTimepoint: Day 90;Mortality in both groupsTimepoint: Day 28 and Day 90;Progression or resolution of Organ failuresTimepoint: Day 90