Terlipressin + Albumin Versus Midodrine + Octreotide in the Treatment of Hepatorenal Syndrome

What Was Tested

This registered phase 2, phase 3 trial tested Octreotide and Terlipressin.

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

Fifty patients with cirrhosis and HRS will be randomly assigned to arm 1.

Fifty patients with cirrhosis and HRS will be randomly assigned to arm 2.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 49 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.

The full record lists 1 inclusion and 5 exclusion criteria; among the exclusions: diagnosis of hcc with a staging beyond the milan criteria di milano; 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 Octreotide group and the comparison group should start out alike.

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

Everyone knew when Octreotide 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 2013-10.

It ran at 1 site in Italy.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: The primary end-point of the study is the complete reform of the renal function (serum creatinine < [amount hidden]/dl. The primary end point will be evaluated at the end of the treatment.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Octreotide and Terlipressin in 49 people.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

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