Terlipressin in Cirrhotic Patients With Recidivation Ascites Treated With Paracentesis and Albumin

What Was Tested

This registered phase 3 trial tested Terlipressin.

Ascites is a common complication of cirrhosis.

Sodium restriction and diuretics are the first step treatment.

Refractory ascites (not responding to first step treatment) is treated with repeated large volume paracentesis followed by intra venous albumin expansion.

It had two arms (groups): Terlipressin (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Total paracentesis is used in patients with cirrhosis and tense ascites.

Who Took Part

The registry lists 82 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Patient aged 18 years old and more with cirrhosis and refractory ascites define by the international ascites club. Vital status non engaged in the 2 months.

The full record lists 2 inclusion and 10 exclusion criteria; among the exclusions: cardiovascular disease : previous or actual angina pectoralis, myocardial infarction, heart failure, rhythm or conduction disorders, repolarisation abnormality on ecg; respiratory disease: previous or actual chronic pulmonary insufficiency, asthma; uncontrolled hypertension.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

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

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

Neither the participants nor the staff measuring them knew who was on Terlipressin, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2009-11 with completion listed for 2015-03.

It ran at 1 site in France.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Mean number of paracentesis between the 2 groups over a 6 months period (time frame: 6 months).

It also tracked 6 secondary outcomes, for example Total ascites retrieval, Number of cirrhosis complications groups, Terlipressin safety, Mean number of days of hospitalization and Delay between inclusion and the first rehospitalisation for ascites retrieval.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Terlipressin in 82 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.