Terlipressin Given As I.V. Boluses Versus Terlipressin Given As Continuous Intravenous Infusion In Patients With Cirrhosis And Type 1 Hepatorenal Syndrome

What Was Tested

The trial (phase 2, phase 3) is built around Terlipressin.

Up to now the two schedules of i.v. administration of terlipressin have never been compared.

It had two arms (groups): 1 (active comparator) and 2 (experimental).

35 patients with cirrhosis and type 1 HRS.

35 patients with cirrhosis and type 1 HRS.

The registry classes the interventions as drug.

Who Took Part

70 planned participants were the target.

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 and type 1 HRS.

The full record lists 1 inclusion and 4 exclusion criteria; among the exclusions: HCC beyond the Milan Criteria,septic shock (systolic arterial pressure \< 90 mmHg,.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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

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

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 2005-05 with completion listed for 2014-12.

It ran at 1 site in Italy.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: The primary end-point of the study is the complete reform of the renal function (creatinine < [amount hidden]/dl).

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Terlipressin in 70 people.

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.