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

17/0508

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.

2022-05-27

2023-10-31

2024-01-31

Active (not recruiting)

Early phase I

30

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': '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.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 30, 'type': 'ACTUAL'}}

2023-05-03