Effect of Terlipressin on Cerebral Oxygen Saturation During Liver Transplantation

What Was Tested

In this phase 2 trial, researchers set out to test Terlipressin.

In their study the investigators aim to assess the effect of terlipressin on cerebral oxygenation monitored by cerebral oxymetry and cerebral blood flow measured by transcranial doppler.

It had two arms (groups): terlipressin group (experimental) and saline (control) group (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Other blood products will be transfused guided by lab result; Fresh frozen plasma will be given when INR \> 2 and platelets will be given when platelets \<30.000/mm3.

Drugs will be prepared by the nurse and the investigator will be blinded to the drug given.

Who Took Part

Enrollment: 30 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: ASA II-IV undergoing orthotopic liver transplantation. Age above 18 years.

The full record lists 2 inclusion and 6 exclusion criteria; among the exclusions: age below 18 years; patients on terlipressin preoperative; patients known allergic to terlipressin.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

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.

Blinding on both sides kept the participants and researchers unaware of who received Terlipressin.

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

It started in 2018-01-25 with completion listed for 2018-11-25.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: cerebral oxygen saturation (time frame: one hour after infusion of drug).

It also tracked 10 secondary outcomes, for example cerebral oxygen saturation, resistive index of middle cerebral artery, peak velocity, end diastolic velocity of middle cerebral arteries, End diastolic velocity of middle cerebral arteries, Heart rate and Systolic blood pressure.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Terlipressin in 30 people.

Its size is small, so on its own it can only give an early look.

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.