A Feasibility Study of Octreotide Infusion During Liver Transplant.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-27

Study Completion Date

2024-01-31

Brief Summary

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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.

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Detailed Description

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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

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Liver Transplantation Renal Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients will be randomised in a 2:1 ratio to either octreotide or placebo groups. Stratified randomisation of patients by source of liver graft (brain death or cardiac death) will be performed.

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Blinding (masking) will be achieved through the use of identical active drug product and control study drug syringes that are allocated by centrally-controlled and administered randomisation such that no clinical, research or statistical support staff are aware of allocation.

Study Groups

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Intervention group

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

Group Type ACTIVE_COMPARATOR

Octreotide Acetate

Intervention Type DRUG

Octreotide syringes will contain 50ml of octreotide acetate at 20mcg/ml in 0.9% w/v sodium chloride in water.

Placebo group

Sodium chloride 0.9% w/v

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Sodium chloride 0.9% w/v

Interventions

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Octreotide Acetate

Octreotide syringes will contain 50ml of octreotide acetate at 20mcg/ml in 0.9% w/v sodium chloride in water.

Intervention Type DRUG

Placebo

Sodium chloride 0.9% w/v

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No