A Feasibility Study of Octreotide Infusion During Liver Transplant.

University College London (UCL)

Status and phase: Active, not recruiting; Phase 2

Conditions: Liver Transplantation; Renal Failure

Treatments: Drug: Octreotide Acetate; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04941911

17/0508

PB-PG-0817-20023 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• Previous solid organ transplant.
• Acute liver failure.
• Fulminant hepatic failure.
• Patients receiving a living donor liver graft.
• Patients currently admitted to ICU prior to transplantation.
• Requirement of haemodialysis or CVVHF pre-operatively.
• Known allergy or adverse reaction to octreotide.
• Pre-operative decision to use intra-operative CVVHF.
• A positive pregnancy test.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

Intervention group

Active Comparator group

Description:

Octreotide intravenous infusion, 100mcg bolus with a subsequent infusion of 100mcg per hour during surgery.

Treatment:

Drug: Octreotide Acetate

Placebo group

Placebo Comparator group

Description:

Sodium chloride 0.9% w/v

Treatment:

Other: Placebo