Clinical trial NCT04941911: A Feasibility Study of Octreotide Infusion During Liver Transplant.
Official title: A Double-blind Randomised Placebo-controlled Feasibility Study to Assess the Impact of Octreotide Infusion During Liver Transplantation on Post-operative Renal Failure.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Liver Transplantation
Renal Failure
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
First posted: 2021-06-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: OTHER

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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Ability to recruit patients.
timeFrame: Approximately 180 days.
measure: Completion of the study intervention.
timeFrame: Approximately 9.5 hours.
Secondary outcomes:
measure: The incidence of acute kidney injury.
timeFrame: Within 24, 72 and 168 hours post-operatively.
measure: Post-operative incidence of a new requirement for renal replacement therapy.
timeFrame: Within 24 hours, 72 hours, one and two weeks post-operatively.
measure: Incidence of new chronic kidney disease or deterioration of chronic kidney disease.
timeFrame: At thirty and ninety days post operative.
measure: Incidence of early allograft dysfunction.
timeFrame: At day seven post-operatively
measure: Patient mortality.
timeFrame: At thirty and ninety days post-operatively.
measure: Intra-operative red blood cell salvage.
timeFrame: Within 24, 72 and 168 hours post-operatively.
measure: Volume of packed red blood cell transfusion.
timeFrame: Intra-operatively and at 24, 72 and 168 hours post-operatively.
measure: Incidence of adverse events secondary to study drug infusion.
timeFrame: Intra-operatively and up to 24 hours post-operatively.
measure: PROMs_ data collection_1
timeFrame: For EuroQoL-5D-5, At Day 1 and at thirty and ninety days post-operatively. Then at 3, 6 & 9 months.
measure: PROMs_ data collection_2
timeFrame: For LDQOL, At Day 1 and at thirty and ninety days post-operatively. Then at 3, 6 & 9 months.
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: University Hospital Birmingham
city: London
country: United Kingdom
facility: Royal Free Hospital
Study officials:
affiliation: University College, London
name: Michael Spiro
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.