A feasibility study of octreotide infusion during liver transplant

• Research type

  Research Study

• Full title

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

• IRAS ID

  278918

• Contact name

  Michael David Spiro

• Contact email

  michaelspiro@nhs.net

• Sponsor organisation

  University College London

• ISRCTN Number

  ISRCTN17573492

• Clinicaltrials.gov Identifier

  NCT04941911

• Duration of Study in the UK

  1 years, 10 months, 28 days

• Research summary

  Background
  Patients who undergo liver transplantation surgery can suffer complications including kidney failure, major bleeding and require blood transfusions. These complications slow down post-operative recovery and increase the chances of death, the liver transplant not working and the need for long-term kidney dialysis.

  The drug octreotide is an artificial version of a natural hormone and has been shown to support kidney function in severe liver disease as well as possibly reduce bleeding during liver transplantation. Octreotide has been used in liver disease and liver transplant. However there are some risks which include changes in heart rate, blood sugar and heart rhythm.

  Aims
  We are proposing to run a small scale study (a ‘feasibility study’) at two transplant centres to investigate the effect of octreotide during liver transplantation surgery. The information we collect will be used to design a larger trial to determine whether octreotide is beneficial to liver transplantation patients and presents value for money.

  Design
  We will recruit thirty patients at two hospitals, twenty will receive octreotide during their surgery and ten will receive a placebo. We will look for improvement in kidney function and a reduction in bleeding, the need for blood transfusion as well as the quality of life reported by patients three months after their surgery.

  We will closely monitor patient’s blood sugar levels, heart rate and rhythm during the study to make sure they are normal. If there are any concerns we can stop giving the octreotide medication. This will allow us to assess the risks posed by octreotide during surgery.

  We will judge this feasibility study a success and aim to proceed to the larger trial if we;
  • Effectively recruit patients
  • Deliver study medication correctly
  • Have a low drug-related serious adverse event rate
  • Achieve good study completion
  • Fully collect data

• REC name

  East Midlands - Leicester South Research Ethics Committee

• REC reference

  21/EM/0076

• Date of REC Opinion

  4 May 2021

• REC opinion

  Further Information Favourable Opinion