Efficacy and Safety of Terlipressin With Albumin Versus Midodrine With Albumin Versus Albumin Alone in Prevention of Paracentesis Induced Circulatory Dysfunction in Cirrhosis

What Was Tested

In this not phased trial, researchers set out to test Terlipressin.

It had three arms (groups): Terlipressin (experimental), Midodrine (active comparator) and Standard Medical Therapy (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 150 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Patients with cirrhosis who undergo Large volume paracentesis (\> 5L). Patients with age from 18-75 years.

The full record lists 2 inclusion and 10 exclusion criteria; among the exclusions: recent gastrointestinal bleeding within 7 days; spontaneous bacterial peritonitis; patients with cardiovascular disease (electrocardiogram, 2d echo).

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Terlipressin and who got the comparison, which limits bias.

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

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

It started in 2017-05-28 with completion listed for 2018-04-30.

It ran at 1 site in India.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Incidence of Paracentesis Induced Circulatory Dysfunction (PICD) (time frame: Day 6).

It also tracked 6 secondary outcomes, for example Number of hospital admission withing 28 days in all the 3 groups, Development of Hyponatremia in all the 3 groups, Development of Hepatic Encephalopathy in all the 3 groups, Recurrence of ascites in all the 3 groups, Development of Acute Kidney Injury in all the 3 groups and Survival in all the 3 groups.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Terlipressin in 150 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.