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Liver TransplantationPhase 2OctreotideNCT04941911

A Feasibility Study of Octreotide Infusion During Liver Transplant.

A Phase 2 study testing Octreotide Acetate in people with Liver Transplantation and Renal Failure, run by University College, London at 2 sites in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Liver Transplantation, Renal Failure
What is being tested?
Octreotide Acetate
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
2 sitesUnited Kingdom
Study dates
27 May 2022to 31 Jan 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • Known allergy or adverse reaction to octreotide.
  • Pre-operative decision to use intra-operative CVVHF.
  • A positive pregnancy test.

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites

  • University Hospital Birmingham

    Birmingham

  • Royal Free Hospital

    London

Other trials in United Kingdom

About this study

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.

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.

Read the 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).

Being tested
Octreotide Acetate, Placebo
Medical subject headings
Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Octreotide AcetateDrug

    Octreotide syringes will contain 50ml of octreotide acetate at 20mcg/ml in 0.9% w/v sodium chloride in water.

  • PlaceboOther

    Sodium chloride 0.9% w/v

Study groups in NCT04941911
Study groupRoleWhat they receive
Intervention groupActive comparatorOctreotide intravenous infusion, 100mcg bolus with a subsequent infusion of 100mcg per hour during surgery.
Receives: Drug: Octreotide Acetate
Placebo groupPlacebo comparatorSodium chloride 0.9% w/v
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ability to recruit patients.

    This will be assessed by:

    • Ability to recruit patients (target: ≥ 30% consent rate of eligible patients admitted for transplant)

    Measured: Approximately 180 days.

  2. 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.

    Measured: Approximately 9.5 hours.

Secondary outcomes (10)

  1. 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).

    Measured: Within 24, 72 and 168 hours post-operatively.

  2. Post-operative incidence of a new requirement for renal replacement therapy.

    Administration of haemofiltration or haemodiafiltration.

    Measured: Within 24 hours, 72 hours, one and two weeks post-operatively.

  3. 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.

    Measured: At thirty and ninety days post operative.

  4. 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.

    Measured: At day seven post-operatively

  5. Patient mortality.

    Patient mortality at thirty and ninety days post-operatively.

    Measured: At thirty and ninety days post-operatively.

  6. Intra-operative red blood cell salvage.

    Total volume of intra-operative red blood cell salvage available for reinfusion following washing and centrifugation.

    Measured: Within 24, 72 and 168 hours post-operatively.

  7. 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.

    Measured: Intra-operatively and at 24, 72 and 168 hours post-operatively.

  8. 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.

    Measured: Intra-operatively and up to 24 hours post-operatively.

  9. 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.

    Measured: For EuroQoL-5D-5, At Day 1 and at thirty and ninety days post-operatively. Then at 3, 6 & 9 months.

  10. 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.

    Measured: For LDQOL, At Day 1 and at thirty and ninety days post-operatively. Then at 3, 6 & 9 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2021
  2. Study start27 May 2022
  3. Primary completion31 Oct 2023 (estimated)
  4. Study completion31 Jan 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04941911
Sponsor's protocol ID
17/0508
Other IDs
PB-PG-0817-20023
Acronym
Octreotide
Status last verified
May 2023
First submitted
20 Apr 2021
Last updated
3 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: There is a plan to provide baseline and outcome data, including PROMs and treatment allocation.

Publications

  • 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.

    PubMed 34857585

  • 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.

    PubMed 41500624

  • 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.

    PubMed 41128798

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Octreotide Acetate in people with Liver Transplantation and Renal Failure, run by University College, London at 2 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ability to recruit patients. (time frame: Approximately 180 days.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04941911, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2023.

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