TYPE 2 HEPATORENAL SYNDROME

What Was Tested

In this phase 3 trial, researchers set out to test Terlipressin.

However, there are very few studies on vasopressors in the management of type 2 HRS.

Terlipressin has been used commonly; however it is costly and not available in some countries.

It had two arms (groups): Terlipressin and Type-2 HRS (active comparator) and Noradrenaline and Type-2 HRS (active comparator).

The registry classes the interventions as drug.

Who Took Part

46 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Absence of shock, fluid losses and treatment with nephrotoxic drug.

The full record lists 4 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.

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 2009-01 with completion listed for 2011-12.

It ran at 1 site in India.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: The primary end point of the study was serum creatinine less than [amount hidden].

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Terlipressin in 46 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.