A feasibility study of octreotide infusion during liver transplant

A double-blind randomised placebo-controlled feasibility study to assess the impact of octreotide infusion during liver transplantation on post-operative renal failure.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN17573492

Enrollment

Registered

2021-10-05

Start date

2021-10-10

Completion date

Unknown

Last updated

2024-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perioperative bleeding, liver transplant Surgery Perioperative bleeding, liver transplant

Interventions

This feasibility study is designed to demonstrate that we can perform the trial safely and effectively before expanding the study to a larger number of hospitals and recruiting the number of patients

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged =18 years 2. Undergoing primary liver transplantation of a whole or partial liver graft from a cardiac or brain dead donor 3. Provision of written informed consent

Exclusion criteria

Exclusion criteria: 1. Previous solid organ transplant 2. Acute liver failure 3. Fulminant hepatic failure 4. Patients receiving a living donor liver graft 5. Patients currently admitted to ICU prior to transplantation 6. Requirement of haemodialysis or Continuous Veno-Venous Hemofiltration (CVVHF) pre-operatively 7. Known allergy or adverse reaction to octreotide 8. Pre-operative decision to use intra-operative CVVHF 9. A positive pregnancy test

Design outcomes

Primary

Measure	Time frame
Feasibility of conducting a randomised controlled trial of octreotide versus placebo infusion during liver transplantation measured using: 1. The recruitment rate, calculated from the number of patients consented to participate in the study and the number of patients approached, during the recruitment period 2. Rate of completion of the study intervention, calculated from the number of patients receiving full study intervention at 4 months and the number of patients enrolled during the recruitment period 3. Incidence of drug-related serious unexpected adverse events (SUSARs), calculated from the number of SUSARs between baseline and 4 months and the number of patients enrolled during the recruitment period 4. Follow-up data collection rate, calculated from the number of complete PROM questionnaires at 3 months and the number of patients enrolled during the recruitment period 5. Patient refusal to enrol, calculated from the number of patients enrolled and the number of eligible patients admitted for transplantation during the recruitment period 6. Clinician refusal rate, calculated from the number of clinician refusals and the number of patients enrolled during the recruitment period	—

Measure

Time frame

Feasibility of conducting a randomised controlled trial of octreotide versus placebo infusion during liver transplantation measured using: 1. The recruitment rate, calculated from the number of patients consented to participate in the study and the number of patients approached, during the recruitment period 2. Rate of completion of the study intervention, calculated from the number of patients receiving full study intervention at 4 months and the number of patients enrolled during the recruitment period 3. Incidence of drug-related serious unexpected adverse events (SUSARs), calculated from the number of SUSARs between baseline and 4 months and the number of patients enrolled during the recruitment period 4. Follow-up data collection rate, calculated from the number of complete PROM questionnaires at 3 months and the number of patients enrolled during the recruitment period 5. Patient refusal to enrol, calculated from the number of patients enrolled and the number of eligible patients admitted for transplantation during the recruitment period 6. Clinician refusal rate, calculated from the number of clinician refusals and the number of patients enrolled during the recruitment period

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Secondary

Measure	Time frame
1. Blood loss measured using intra-operative cell salvage volume during each surgical phase 2. Intra-operative urine output measured during each surgical phase 3. Mean arterial blood pressure measured during each surgical phase 4. Requirement for and mean vasopressor and/or inotrope infusion rate measured during each surgical phase, 5. Transfusion requirements measured from the de novo packed red blood cells and all clotting products required during surgery and on the ICU within the first 24 h, within the first 72 h, and within the first week 6. Incidence of Acute Kidney Injury (AKI) measured using the Acute Kidney Injury Network stage 1 criteria within the first 24 h, within the first 72 h, and within the first week 7. Incidence of postoperative renal replacement therapy (RRT) measured at 24 h, 72 h, 1, and 2 weeks 8. Incidence of new or worsened chronic kidney disease (CKD) measured using eGFR and KDIGO status at 30 and 90 days. New or worsened CKD is defined as a new persistent estimated glomerular filtration rate 2000 IU/l within the first 7 days post-operatively 12. Incidence of liver graft loss (primary non function) measured at 30 and 90 days 13. Liver graft function measured using INR, bilirubin, AST, ALT, and ALP at 30 and 90 days 14. Patient recorded outcome measures (PROM) measured using the Liver Disease Quality of Life questionnaire and the EuroQOL-5D-5L questionnaire preoperatively and at 90 days 15. The incidence of major safety outcomes be measured throughout the study and will include: 15.1. Unexpected or resistant bradycardia 15.2. New or worsening QTc interval or associated arrhythmia 15.3. Unexpected or resistant hypoglycaemia 15.4. Potential allergic or anaphylactic reaction to any medication	—

Measure

Time frame

1. Blood loss measured using intra-operative cell salvage volume during each surgical phase 2. Intra-operative urine output measured during each surgical phase 3. Mean arterial blood pressure measured during each surgical phase 4. Requirement for and mean vasopressor and/or inotrope infusion rate measured during each surgical phase, 5. Transfusion requirements measured from the de novo packed red blood cells and all clotting products required during surgery and on the ICU within the first 24 h, within the first 72 h, and within the first week 6. Incidence of Acute Kidney Injury (AKI) measured using the Acute Kidney Injury Network stage 1 criteria within the first 24 h, within the first 72 h, and within the first week 7. Incidence of postoperative renal replacement therapy (RRT) measured at 24 h, 72 h, 1, and 2 weeks 8. Incidence of new or worsened chronic kidney disease (CKD) measured using eGFR and KDIGO status at 30 and 90 days. New or worsened CKD is defined as a new persistent estimated glomerular filtration rate 2000 IU/l within the first 7 days post-operatively 12. Incidence of liver graft loss (primary non function) measured at 30 and 90 days 13. Liver graft function measured using INR, bilirubin, AST, ALT, and ALP at 30 and 90 days 14. Patient recorded outcome measures (PROM) measured using the Liver Disease Quality of Life questionnaire and the EuroQOL-5D-5L questionnaire preoperatively and at 90 days 15. The incidence of major safety outcomes be measured throughout the study and will include: 15.1. Unexpected or resistant bradycardia 15.2. New or worsening QTc interval or associated arrhythmia 15.3. Unexpected or resistant hypoglycaemia 15.4. Potential allergic or anaphylactic reaction to any medication

—

Countries

England, United Kingdom

Contacts

Public ContactStudy Team

situ.octreotide@ucl.ac.uk+44 (0)2076799280

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026