Health Condition 1: K769- Liver disease, unspecified
Conditions
Interventions
Intervention1: Terlipressin and Albumin: Dose and Frequency: Injection terlipressin 2 mg/24 hours
Route of Administration: intravenous
Duration of therapy:maximum 14 days or till primary end achieved
Sponsors
Institute of Liver and Biliary Sciences
Eligibility
Inclusion criteria
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
Exclusion criteria: At Admission: 1) Age 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acute Kidney Injury reversal by day 7 in both groupsTimepoint: Day 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Events in both groupsTimepoint: Day 90;Mortality in both groupsTimepoint: Day 28 and Day 90;Progression or resolution of Organ failuresTimepoint: Day 90 | — |
Countries
India
Contacts
Public ContactDr Ankur Jindal
Institute of Liver and Biliary Sciences
Outcome results
None listed