Terlipressin Infusion Alone Vs Terlipressin With Noradrenaline Infusion In The Treatment of Hepatorenal Syndrome Type 1

What Was Tested

This registered phase 3 trial tested Terlipressin.

Hepatorenal syndrome (HRS) is defined as a functional renal failure in a patient with chronic liver disease, or liver cirrhosis.The splanchnic circulation undergoes severe vasodilation, as a result of portal hypertension, causing an underfilling of systemic arteries.This results in intense renal vasoconstriction and functional renal failure.

The best treatment options for HRS I would be a drug which has renal vasodilator property and additional splanchnic vasoconstriction.

It had two arms (groups): TERLIPRESSIN GROUP (active comparator) and TERLIPRESSIN WITH NORADRENALINE GROUP (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 60 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age\>18 years and \<80 yrs;. Cirrhosis as diagnosed by clinical findings, endoscopy or USG examination or by liver biopsy. HRS I as defined by the following features:. The patient should have Cirrhosis and also ascites. There should be absence of shock.

The full record lists 12 inclusion and 6 exclusion criteria; among the exclusions: any history of coronary artery disease, peripheral vascular disease, arrhythmias, and cardiomyopathy; hepatocellular carcinoma; septic shock.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Because people in this Terlipressin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Terlipressin group and the comparison group ran side by side rather than switching.

Being open-label, the Terlipressin study did not mask who received what.

It started in 2019-01-28 with completion listed for 2020-01-30.

It ran at 1 site in India.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of patients responding to treatment (time frame: 15 days).

It also tracked 2 secondary outcomes, for example Number of patients who will develop adverse events due to drugs used for treatment and Number of patients surviving without transplant.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Terlipressin in 60 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Terlipressin compound page, all human trials.