NCT04941911

A Feasibility Study of Octreotide Infusion During Liver Transplant.

A Double-blind Randomised Placebo-controlled Feasibility Study to Assess the Impact of Octreotide Infusion During Liver Transplantation on Post-operative Renal Failure.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University College, London · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to determine whether an octreotide infusion during liver transplantation improves renal outcomes, intraoperative blood pressure and reduces haemorrhage and transfusion requirement.

Detailed description

Common and serious complications of liver transplantation surgery include renal failure, haemorrhage and blood transfusion. These complications prolong post-operative recovery, increase the risk of liver graft failure, mortality and the need for long-term renal dialysis. The drug octreotide is a synthetic analogue of somatostatin with comparable physiological effects and a good side-effect profile. Existing evidence in liver transplantation supports octreotide efficacy in improving renal function, reducing bleeding and enhancing blood pressure. 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. The patients will be randomised in a 2:1 ratio to either octreotide or placebo groups. Stratified randomisation of patients is by donation type (DCD vs. DBD). Patients will be randomised in the anaesthetic room and study medication given as an initial bolus of 5ml (100mcg octreotide or saline) prior to surgical incision and then continued throughout surgery at 5ml/hr (100mcg/hour octreotide or saline).

Conditions

• Liver Transplantation
• Renal Failure

Interventions

Type	Name	Description
DRUG	Octreotide Acetate	Octreotide syringes will contain 50ml of octreotide acetate at 20mcg/ml in 0.9% w/v sodium chloride in water.
OTHER	Placebo	Sodium chloride 0.9% w/v

Timeline

• Start date: 2022-05-27
• Primary completion: 2023-10-31
• Completion: 2024-01-31
• First posted: 2021-06-28
• Last updated: 2023-05-03

Locations

2 sites across 1 country: United Kingdom