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| ID | Type | Description | Link |
|---|---|---|---|
| PB-PG-0817-20023 | Other Grant/Funding Number | NIHR Research for Patient Benefit |
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| Name | Class |
|---|---|
| National Institute for Health Research, United Kingdom | OTHER_GOV |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Active Comparator | Octreotide intravenous infusion, 100mcg bolus with a subsequent infusion of 100mcg per hour during surgery. |
|
| Placebo group | Placebo Comparator | Sodium chloride 0.9% w/v |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Octreotide Acetate | Drug | Octreotide syringes will contain 50ml of octreotide acetate at 20mcg/ml in 0.9% w/v sodium chloride in water. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of acute kidney injury. | This will be defined by Acute Kidney Injury Network stage 1 criteria (a 50% increase in serum creatinine from baseline or less than 0.5 ml/kg/hr urine output for 6-12 hours post-transplant). | Within 24, 72 and 168 hours post-operatively. |
| Post-operative incidence of a new requirement for renal replacement therapy. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Spiro | University College, London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Birmingham | Birmingham | United Kingdom | ||||
| Royal Free Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34857585 | Background | 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. | |
| 41500624 | Derived | 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. |
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There is a plan to provide baseline and outcome data, including PROMs and treatment allocation.
Commencement only after publication of this trial and any subsequent substantive trial.
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.
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D015282 | Octreotide |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
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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.
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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.
| Placebo | Other | Sodium chloride 0.9% w/v |
|
Administration of haemofiltration or haemodiafiltration. |
| Within 24 hours, 72 hours, one and two weeks post-operatively. |
| Incidence of new chronic kidney disease or deterioration of chronic kidney disease. | This is defined as a new persistent estimated glomerular filtration rate below 60 ml/min/1.73m2 or a decline in pre-existing glomular function to a more severe KDIGO chronic kidney disease. status. | At thirty and ninety days post operative. |
| Incidence of early allograft dysfunction. | Early allograft dysfunction defined by the presence of one or more of the following: total bilirubin ≥ 10 mg/dL (171 μmol/L) or, INR ≥ 1.6 on day 7, and ALT/AST > 2,000 IU/L within the first 7 days post-operatively. | At day seven post-operatively |
| Patient mortality. | Patient mortality at thirty and ninety days post-operatively. | At thirty and ninety days post-operatively. |
| Intra-operative red blood cell salvage. | Total volume of intra-operative red blood cell salvage available for reinfusion following washing and centrifugation. | Within 24, 72 and 168 hours post-operatively. |
| Volume of packed red blood cell transfusion. | Volume of packed red blood cell transfusion administered intra-operatively and at 24, 72 and 168 hours post-operatively. | Intra-operatively and at 24, 72 and 168 hours post-operatively. |
| Incidence of adverse events secondary to study drug infusion. | Recorded adverse events are: abnormal QTc interval (460ms in men, 470ms in women) or associated ventricular arrhythmia or Torsades de Pointes, unexpected or resistant hypoglycaemia (blood sugar < 4mM) and clinical suspicion of allergic or anaphylactic reaction. | Intra-operatively and up to 24 hours post-operatively. |
| PROMs_ data collection_1 | PROMs (Patient Recorded Outcome Measures) of quality of life . The questionnaires to be used to quantify quality of life is EuroQoL-5D-5L. | For EuroQoL-5D-5, At Day 1 and at thirty and ninety days post-operatively. Then at 3, 6 & 9 months. |
| PROMs_ data collection_2 | PROMs (Patient Recorded Outcome Measures) of quality of life . The questionnaires to be used to quantify quality of life is LDQOL. | For LDQOL, At Day 1 and at thirty and ninety days post-operatively. Then at 3, 6 & 9 months. |
| London |
| United Kingdom |
| 41128798 | Derived | Zhu X, Qiao Y, Liu W, Zhu J, Shen H, Huang Y, Lai R, Nan G, Shu M, Jia J. The Scar-suppressing Efficiency of Three Sutures with Different Degradation Rates: A Prospective Split-Scar Study. Aesthetic Plast Surg. 2026 May;50(9):3497-3506. doi: 10.1007/s00266-025-05288-8. Epub 2025 Oct 23. |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000602 |
| Amino Acids, Peptides, and Proteins |