Protocol for a prospective double-blind, randomised, placebo-controlled feasibility trial of octreotide infusion during liver transplantation

What Was Tested

This clinical study looks at Octreotide.

However, serious complications are common and include major haemorrhage, hypotension and renal failure.

However, octreotide does have risks, including resistant bradycardia, hyperglycaemia and hypoglycaemia and QT prolongation.

Who Took Part

The abstract describes 30 patients taking part.

PubMed indexes the participants as adults.

The researchers will recruit 30 adult patients at two liver transplant centres.

These include the recruitment ratio, correct administration of blinded study intervention, adverse event rates, patient and clinician enrolment refusal and completion of data collection.

How the Study Was Run

In design terms this was a randomized, double-blind, placebo-controlled and multicenter study.

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

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

The comparison arm used a placebo, so changes seen with Octreotide could be set against what happens without it.

Running at several centres spread the Octreotide study over different clinics and patient groups.

The researchers describe a multicentre, double-blind, randomised, placebo-controlled feasibility study of continuous infusion of octreotide during liver transplantation surgery.

A blinded infusion during surgery will be administered in a 2:1 ratio of octreotide:placebo.

The primary outcomes will determine the feasibility of this study design.

No formal statistical tests are planned.

This manuscript represents study protocol number 1.3, dated 2 June 2021.

What Was Measured

The main study outcomes will be submitted to an open-access journal.

Topics PubMed links to this paper include COVID-19, Feasibility Studies, Liver Transplantation, Octreotide, Quality of Life and Randomized Controlled Trials as Topic.

Author keywords: adult anaesthesia, adult intensive & critical care, hepatobiliary disease, hepatobiliary surgery, hepatology and transplant surgery.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Octreotide in 30 patients.

With fewer than 40 people, it is a small study, so it is better read as an early signal for further research than as a settled answer.

The publication is from 2021 (BMJ open), a journal based in England.

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