Comparison of Terlipressin and low dose Terlipressin and noradrenalin in HRS-AKI patients of ACLF
Phase 2
- Conditions
- Health Condition 1: K77- Liver disorders in diseases classified elsewhere
- Registration Number
- CTRI/2023/10/058546
- Lead Sponsor
- on sponsered
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
ACLF as per APASL criteria
AKI at admission as defined by ICA-AKI criteria
HRS-AKI grade II & grade III as defined by ICA 12 hour of admission
Exclusion Criteria
Age <18 years >70 years
Septic shock
Patient with HCC outside Milan’s criteria
Severe Hyponatremia (Na <120 MEq/L)
Patients with RH failure, CAD, PVD, arrhythmias and cardiomyopathy
Pregnancy or Lactating mother
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AKI reversal by day 7Timepoint: AKI reversal by day 7
- Secondary Outcome Measures
Name Time Method Comparison of Partial/1 stage regression of AKI at 48 hour <br/ ><br> Complete reversal of HRS maximum by day 15 <br/ ><br> Liver transplantation <br/ ><br> Mortality at day 28, day 90 <br/ ><br> Progression or resolution of OFs <br/ ><br> Treatment related adverse effects & their gradesTimepoint: 90 days