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Comparison of Terlipressin and low dose Terlipressin and noradrenalin in HRS-AKI patients of ACLF

Comparison of outcome in Terlipressin and ultra-low dose Terlipressin plus noradrenalin infusion in HRS-AKI patients of ACLF - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/10/058546
Enrollment
140
Registered
2023-10-11
Start date
Unknown
Completion date
Unknown
Last updated
2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K77- Liver disorders in diseases classified elsewhere

Interventions

Intervention1: Low dose terlipressin plus noradrenalin arm: Terlipressin 0.25 mg 6 Hrly iv bolus, fixed dose • Noradrenaline, which would be given as a continuous infusion at a starting dose of 0.1µg/

Sponsors

Non sponsered
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: Age 70 years Septic shock Patient with HCC outside Milan’s criteria Severe Hyponatremia (Na 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

Design outcomes

Primary

MeasureTime frame
AKI reversal by day 7Timepoint: AKI reversal by day 7

Secondary

MeasureTime frame
Comparison of Partial/1 stage regression of AKI at 48 hour Complete reversal of HRS maximum by day 15 Liver transplantation Mortality at day 28, day 90 Progression or resolution of OFs Treatment related adverse effects & their gradesTimepoint: 90 days

Countries

India

Contacts

Public ContactChandan kumar

Institute of liver and biliary sciences

Vinod_ucms@yahoo.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026