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

Abstract

<jats:sec><jats:title>Introduction</jats:title><jats:p>Liver transplantation is a complex operation that can provide significant improvements in quality of life and survival to the recipients. However, serious complications are common and include major haemorrhage, hypotension and renal failure. Blood transfusion and the development of acute kidney injury lead to both short-term and long-term poor patient outcomes, including an increased risk of death, graft failure, length of stay and reduced quality of life. Octreotide may reduce the incidence of renal dysfunction, perioperative haemorrhage and enhance intraoperative blood pressure. However, octreotide does have risks, including resistant bradycardia, hyperglycaemia and hypoglycaemia and QT prolongation. Hence, a randomised controlled trial of octreotide during liver transplantation is needed to determine the cost-efficacy and safety of its use; this study represents a feasibility study prior to this trial.</jats:p></jats:sec><jats:sec><jats:title>Methods and analysis</jats:title><jats:p>We describe a multicentre, double-blind, randomised, placebo-controlled feasibility study of continuous infusion of octreotide during liver transplantation surgery. We will recruit 30 adult patients at two liver transplant centres. 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. These include the recruitment ratio, correct administration of blinded study intervention, adverse event rates, patient and clinician enrolment refusal and completion of data collection. Secondary outcome measures of efficacy and safety will help shape future trials by assessing potential primary outcome measures and monitoring safety end points. No formal statistical tests are planned. This manuscript represents study protocol number 1.3, dated 2 June 2021.</jats:p></jats:sec><jats:sec><jats:title>Ethics and dissemination</jats:title><jats:p>This study has received Research Ethics Committee approval. The main study outcomes will be submitted to an open-access journal.</jats:p></jats:sec><jats:sec><jats:title>Trial sponsor</jats:title><jats:p>The Joint Research Office, University College London, UK.</jats:p><jats:p>Neither the sponsor nor the funder have any role in study design, collection, management, analysis and interpretation of data, writing of the study report or the decision to submit the report for publication.</jats:p></jats:sec><jats:sec><jats:title>Trial registration</jats:title><jats:p>The study is registered with ClinicalTrials.gov (<jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="clintrialgov" xlink:href="NCT04941911">NCT04941911</jats:ext-link>) with recruitment due to start in August 2021 with anticipated completion in July 2022.</jats:p></jats:sec><jats:sec><jats:title>Clinical trials unit</jats:title><jats:p>Surgical and Interventional Group, Division of Surgery &amp; Interventional Science, University College London.</jats:p></jats:sec>