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A clinical trial to study the effect of bolus vs continuous infusion of terlipressin for treatment of hepatorenal syndrome in cirrhosis of liver.

Comparison of bolus vs continuous infusion of terlipressin for treatment of hepato renal syndrome in cirrhosis of liver - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/09/073524
Enrollment
100
Registered
2024-09-06
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Health Condition 1: K746- Other and unspecified cirrhosis ofliver

Interventions

Intervention1: Terlipressin Infusion: Terlipressin will be given in infusion form. Starting dose will be of 2 mg/day. For the continuous intravenous infusion, the dose of terlipressin will be disso

Sponsors

SCB medical college
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Cirrhosis as diagnosed by clinical, biochemical,ultrasound, endoscopy finding and or liver biopsy if needed. 2. Age 18years to 75 years 3. Diagnosis of type 1 HRS AKI as defined by the criteria of the International Club of Ascites ICA The following criteria will be followed for the diagnosisof HRS AKI a. Cirrhosis with ascites, b. Increase in serum creatinine 0.3 mg per dL within 48 hours or 50 percent frombaseline value, known or presumed, to have occurred within the prior 7 days and or urine output less than 0.5 mL per kg for 6 hr. c Absence of improvement in serum creatinine and or urine output within 24 hours following adequate volume resuscitation when clinicallyindicated and d. Absence of strong evidence for an alternative explanation as theprimary cause of AKI.

Exclusion criteria

Exclusion criteria: Following cirrhoticpatients were excluded: (1) Hepatocellularcarcinoma . (2) Septic shock; (3) Cardiac or respiratory failure or other severe extrahepatic disease; or (4) Contraindications to the use ofterlipressin.

Design outcomes

Primary

MeasureTime frame
To assess the efficacy of terlipressin infusion in comparison to terlipressin bolus injection for achieving complete response in patients of cirrhosis with HRS -AKI â?¢ Complete response is defined as decline in serum creatinine less than 1.5 mg/dl. Timepoint: Primary outcome will be assessed at any time when complete response is achieved after start of treatment till the end of treatment at 14 days.

Secondary

MeasureTime frame
1.To assess the development of terlipressin induced adverse event between the two groups 2. To compare the 90-day transplant-free survival between two groups. Timepoint: secondary outcome will be assessed at 90 days

Countries

India

Contacts

Public ContactDr Sambit Kumar Patel

Department of Hepatology

scbhepatology@gmail.com9437151276

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026