The Effect of Terlipressin in the Prevention of Type 2 Hepatorenal Syndrome by Improving Mean Arterial Pressure

What Was Tested

In this phase 4 trial, researchers set out to test Terlipressin.

Appreciation of the central role for arterial vasodilatation in the pathogenesis of hepatorenal syndrome (HRS) has led to routine use of vasoconstrictors in combination with albumin as a medical therapy for HRS.

Terlipressin have been explored but the optimal approach for such therapies has not yet been established.

It had two arms (groups): Terlipressin and albumin (active comparator) and Albumin (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

30 planned participants were the target.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Cirrhosis as diagnosedby liver biopsy or clinical, biochemical, ultrasound,and/or endoscopic findings;. Type 2 HRS with a MAP decrees for at least 10mmHg compared to basal blood pressure ;. Age 18 to65 years;. The absence of cardiovascular diseases and any extra hepatic disease that could affect the short-term prognosis;. The absence of advanced hepatocellularcarcinoma.

The full record lists 7 inclusion and 4 exclusion criteria; among the exclusions: patients with history of coronary artery disease; ventricular arrhythmia; obstructive arterial disease of limbs -.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

The participants were allocated by chance, so the Terlipressin group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when Terlipressin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2015-07 with completion listed for 2017-07.

It ran at 1 site in China.

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: HRS incidence rate (time frame: one year).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Terlipressin in 30 people.

Its size is small, so on its own it can only give an early look.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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