A Feasibility Study of Octreotide Infusion During Liver Transplant.

What Was Tested

The trial (phase 2) is built around Octreotide.

It had two arms (groups): Intervention group (active comparator) and Placebo group (placebo comparator).

The registry classes the interventions as drug and other.

More on the Plan

Common and serious complications of liver transplantation surgery include renal failure, haemorrhage and blood transfusion.

The drug octreotide is a synthetic analogue of somatostatin with comparable physiological effects and a good side-effect profile.

However, there is no robust randomised controlled trial evidence for octreotide in liver transplantation and limited safety data regarding its use in this setting.

This is a multi centre, prospective double-blind, randomised, placebo-controlled trial of octreotide infusion during liver transplantation.

Who Took Part

The registry lists 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: Adults aged 18 years and over undergoing primary liver transplantation of a whole or partial liver graft from a cardiac or brain dead donor. Provision of written informed consent.

The full record lists 2 inclusion and 9 exclusion criteria; among the exclusions: previous solid organ transplant; acute liver failure; fulminant hepatic failure.

How the Study Was Run

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

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

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

As a double-blind Octreotide study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2022-05-27 with completion listed for 2023-10-31.

It ran at 2 sites in United Kingdom (2).

Its stated primary purpose is other.

What Was Measured

Primary outcome: Ability to recruit patients (time frame: Approximately 180 days). Completion of the study intervention (time frame: Approximately 9.5 hours).

It also tracked 10 secondary outcomes, for example The incidence of acute kidney injury, Post-operative incidence of a new requirement for renal replacement therapy, Incidence of new chronic kidney disease or deterioration of chronic kidney disease, Incidence of early allograft dysfunction, Patient mortality and Intra-operative red blood cell salvage.

What This Means in Plain Language

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

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

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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