A Feasibility Study of Octreotide Infusion During Liver Transplant.

NCT04941911 | Unknown Phase 2

• 2 other identifiers: 17/0508PB-PG-0817-20023
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Liver Transplantation; Renal Failure

Outcome Measures

Primary Outcomes (2)

• Ability to recruit patients.

  This will be assessed by: • Ability to recruit patients (target: ≥ 30% consent rate of eligible patients admitted for transplant)

  Approximately 180 days.

• Completion of the study intervention.

  This will be assessed by: • The percentage of patients successfully completing the study intervention. Defined as eligible patients who receive the entire study drug infusion in a blinded manner.

  Approximately 9.5 hours.

Secondary Outcomes (10)

• The incidence of acute kidney injury.

  Within 24, 72 and 168 hours post-operatively.

• Post-operative incidence of a new requirement for renal replacement therapy.

  Within 24 hours, 72 hours, one and two weeks post-operatively.

• Incidence of new chronic kidney disease or deterioration of chronic kidney disease.

  At thirty and ninety days post operative.

• Incidence of early allograft dysfunction.

  At day seven post-operatively

• Patient mortality.

  At thirty and ninety days post-operatively.

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

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

Drug: Octreotide Acetate

Placebo group

PLACEBO COMPARATOR

Sodium chloride 0.9% w/v

Other: Placebo

Interventions

Octreotide Acetate DRUG

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

Intervention group

Placebo OTHER

Sodium chloride 0.9% w/v

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University College, London: lead
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (2)

University Hospital Birmingham

Birmingham, United Kingdom

Location

Royal Free Hospital

London, United Kingdom

Location

Related Publications (2)

• Fabes J, Ambler G, Shah B, Williams NR, Martin D, Davidson BR, Spiro M. Protocol for a prospective double-blind, randomised, placebo-controlled feasibility trial of octreotide infusion during liver transplantation. BMJ Open. 2021 Dec 2;11(12):e055864. doi: 10.1136/bmjopen-2021-055864.

  PMID: 34857585 BACKGROUND

• Coppack KES, Kantsedikas I, Brodkin E, Loh EN, Ambler G, Moonesinghe SR, Fabes J, Hannon V, Spiro M, Wagstaff D. Understanding recruitment to a randomised controlled trial (RCT) during liver transplantation: an observational mixed-methods Study Within A Trial (SWAT). BMJ Open. 2026 Jan 7;16(1):e104310. doi: 10.1136/bmjopen-2025-104310.

  PMID: 41500624 DERIVED

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Octreotide

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Michael Spiro

  University College, London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 20, 2021
• First Posted: June 28, 2021
• Study Start: May 27, 2022
• Primary Completion: October 31, 2023
• Study Completion: January 31, 2024
• Last Updated: May 3, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Commencement only after publication of this trial and any subsequent substantive trial.
• Access Criteria: We would only provide IPD on specific application for that data as part of meta-analysis or other comparable research, rather than providing an 'open book' approach. Eligible requests will come from genuine non-commercial research institutes with a plan to publish meta-analytical or systematic review outcomes. Requests will be reviewed by the TMG with discussion with the TSC as needed. Data will be provided in a basic spreadsheet database via institutional email, ensuring no PID is contained.

Locations

GB (2)