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Clinical Trials/CTRI/2024/09/074406
CTRI/2024/09/074406Not yet recruitingPhase 4

Open labelled randomized control study on continuous intravenous infusion versus intravenous boluses of terlipressin in the management of HRS

Aster Medcity1 site in 1 country60 target enrollmentStarted: October 10, 2024Last updated:

Trial Snapshot

Phase
Phase 4
Status
Not yet recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
Response to treatment:

Study Overview

Brief Summary

Hepatorenal syndrome is a severe complication of cirrhosis of live that occurs characteristically in patients with ascites. Terlipressin plus albumin is the most commonly used therapeutic option for the treatment of hepatorenal syndrome. According to the peripheral arterial vasodilation hypothesis, terlipressin was introduced to counteract the splanchanic arterial vasodilation to reduce portal hypertension and to improve the reduced effective circulating volume, both thought to be pivotal factors in the pathogenesis of HRS. The effect of terlipressin on splanchnic hemodynamics, namely the reduction of portal pressure, was tested in patients with cirrhosis, it was shown that it lasted no more than 3 to 4 hours after the intravenous olus of the drug. Therefor, this cannot ensure that the drug is able to exert its positive effect on arterial splanchnic hemodynamics and continue to maintain its effect for 24 hours. Terlipressin given by continous intravenous infusion was found to be effective even when given at low dose, suggesting that it may be effective at doses lower than those required for intravenous bolus adminstration.

This Randomised control trial has been designated to evaluate whether terlipressin given by continuous intravenous infusion is more suitable approach than terlipressin given by intravenous boluses in the treatment of HRS-AKI.

Study hypothesis is that terlipressin given by infusion is safer, efficacious at lower doses when compared to Terlipressin given as intermittent boluses.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 99.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Diagnosed case of cirrhosis of liver.
  • Age more than 18 years.
  • Diagnosis of hepatorenal syndrome as defined by modified criteria of internal club of ascites.

Exclusion Criteria

  • Septic shock.
  • Coronary Artery Disease.
  • Hepatocellular carcinoma BCLCD
  • Post Renal AKI.

Outcomes

Primary Outcomes

Response to treatment:

Time Frame: Treatment will be continued till complete resolution of HRS AKI or Maximum of 14 days of treatment. Treatemnt will be discontinued in patients who develop serious adverse effects or exit from the study.

1. Complete response.

Time Frame: Treatment will be continued till complete resolution of HRS AKI or Maximum of 14 days of treatment. Treatemnt will be discontinued in patients who develop serious adverse effects or exit from the study.

2. Partial response

Time Frame: Treatment will be continued till complete resolution of HRS AKI or Maximum of 14 days of treatment. Treatemnt will be discontinued in patients who develop serious adverse effects or exit from the study.

3. No response

Time Frame: Treatment will be continued till complete resolution of HRS AKI or Maximum of 14 days of treatment. Treatemnt will be discontinued in patients who develop serious adverse effects or exit from the study.

Secondary Outcomes

  • Safety of treatment defined as prevalence of adverse events in both the groups(Till end of treatemnt)

Investigators

Sponsor
Aster Medcity
Sponsor Class
Private hospital/clinic
Responsible Party
Principal Investigator
Principal Investigator

Beeravelli Rajesh

Aster Medcity

Study Sites (1)

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