Terlipressin Administration in Patients Undergoing Major Liver Resection

What Was Tested

This registered phase 2 trial tested Terlipressin.

It had two arms (groups): Terlipressin (active comparator) and NaCl (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Liver regeneration depends on a correct portal pressure and portal blood flow.

In the preliminary results the investigators show an elevation of portal pressure post partial hepatectomy in mice.

Liver regeneration depends on a correct portal pressure and portal blood flow.

Aim: To perform a prospective randomized trial comparing terlipressin versus placebo in patients undergoing major hepatic resection.

Who Took Part

150 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: Patients undergoing resection of 3 or more liver segments. Minimum age of 18. Written informed consent.

The full record lists 4 inclusion and 12 exclusion criteria; among the exclusions: severe liver dysfunction (child-turcotte-pugh grade c); severe aortic regurgitation, severe mitral regurgitation, heart failure; symptomatic coronary heart disease.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

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.

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 and investigator.

It started in 2013-11 with completion listed for 2018-03.

It ran at 1 site in Switzerland.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of patients with incident of a composite end point (time frame: one month).

It also tracked 7 secondary outcomes, for example Number of patients with pleural effusion, Number of patients with surgical site infection, Number of patients with sepsis, Number of patients with pneumonia, Number of patients with intraabdominal hematoma and Number of patients with acute renal failure.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Terlipressin in 150 people.

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

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