Status:
COMPLETED
Efficacy of Early Terlipressin Plus Albumin Therapy in Comparison to Standard Treatment for HRS-AKI in Acute-on-chronic Liver Failure.
Lead Sponsor:
Institute of Liver and Biliary Sciences, India
Conditions:
Acute-On-Chronic Liver Failure
Hepatorenal Syndrome
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Acute on chronic liver failure (ACLF) is a distinct entity where, because of severe acute hepatic injury, a rapid loss of liver function develops in a patient with previous chronic liver disease(4). T...
Detailed Description
Aim To compare the effect of Early initiation of Terlipressin (ET arm) to albumin at 12 hour in ACLF patients with non-volume responsive AKI versus standard Terlipressin (ST arm) at 48 hours. Primary...
Eligibility Criteria
Inclusion
- Age 18-65 years
- ACLF as per APASL criteria
- AKI at admission as defined by ICA-AKI criteria
- AKI stage 2/3 at 12 hour of admission
Exclusion
- \-
- At Admission:
- Age \<18 years
- Patients on renal replacement therapy (RRT)
- Post renal or liver transplantation
- History of CAD, ischemic cardiomyopathy, PVD, ventricular arrhythmia
- Decompensated cirrhosis not fulfilling ACLF criteria
- Cirrhotics with AKI managed as outpatients
- Grade III/IV HE or Shock requiring inotropes or patients on mechanical ventilator at time of randomization
- In-hospital new AKI
- Active urinary sediments - 2+ albumin or above, dysmorphic RBCs
- Known CKD, obstructive uropathy
- Lack of informed consent
- 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
Key Trial Info
Start Date :
June 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 10 2022
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04416282
Start Date
June 22 2020
End Date
June 10 2022
Last Update
April 6 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, India, 110070