Normothermic Versus Hypothermic Cardiopulmonary Bypass in Adult Cardiac Surgery: a Multicentre Feasibility Randomised Controlled Trial

Status: Recruiting
Location: See all (11) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

In order to perform heart surgery, a machine called cardiopulmonary bypass (CPB), or more commonly known as a heart-lung machine, is used to maintain the circulation of oxygenated blood needed by the rest of the body and its organs. Historically, when a patient is connected to CPB, their body is cooled below the normal body temperature. This is known as hypothermia. This is because scientific studies have previously shown that reduced body temperature lowers metabolism and therefore offers more protection to the brain and other organs due to the reduced oxygen requirement. The evidence supporting this practice, however, has been challenged throughout the history of cardiac surgery, with studies supporting that normothermia, or normal body temperature, is a safe alternative. Despite this, the practice of hypothermia has persisted. Published data from a survey of 139 cardiac surgeons in the United Kingdom showed that 84% still routinely employ hypothermic CPB during surgery. To assess whether normothermic or hypothermic CPB is safer, a clinical trial requiring a large sample size and high recruitment rates will be required. Therefore, the investigators aim to assess firstly the feasibility of trial recruitment and allocation adherence in this study. 100 adults across 10 different cardiac surgery centres in the United Kingdom will be recruited to a multicentre feasibility randomised controlled trial comparing normothermia (active comparator) against hypothermia (control comparator) during cardiopulmonary bypass in cardiac surgery. This study will also test the ability of the Cardiothoracic Interdisciplinary Research Network (CIRN), a trainee-led research collaborative, to collect pilot data on Major Adverse Cardiac and Cerebrovascular Events (MACCE) using a regulation-approved electronic application HealthBitⓇ. Participants will also be asked to complete quality of life surveys. The results of this study will subsequently inform a large, adequately powered randomised controlled trial for optimal temperature management during CPB.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ Participants may enter the trial if all of the following apply

• Adult patients (≥ 18 years) scheduled for coronary artery bypass surgery and/or valve replacement/ repair, either in the elective or urgent setting.

• European System for Cardiac Operative Risk Evaluation (EuroSCORE) II of 2 or higher.

• Able to understand and communicate to provide informed consent.

• Able to read and understand the English language.

Locations
Other Locations
United Kingdom
Blackpool Victoria Hospital, Blackpool Teaching Hospitals NHS Foundation Trust
NOT_YET_RECRUITING
Blackpool
University Hospitals Bristol and Weston NHS Foundation Trust
RECRUITING
Bristol
Castle Hill Hospital, Hull University Teaching Hospitals NHS Trust
RECRUITING
Cottingham
Golden Jubilee National Hospital, NHS Golden Jubilee
RECRUITING
Glasgow
Glenfield Hospital, University Hospitals of Leicester NHS Trust
RECRUITING
Leicester
Harefield Hospital, Guy's and St Thomas' NHS Foundation Trust
NOT_YET_RECRUITING
London
King's College Hospital, King's College Hospital NHS Foundation Trust
RECRUITING
London
Royal Brompton Hospital, Guy's and St Thomas' NHS Foundation Trust
NOT_YET_RECRUITING
London
John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust
RECRUITING
Oxford
Derriford Hospital, Plymouth University Hospitals NHS Trust
RECRUITING
Plymouth
Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation Trust
RECRUITING
Sheffield
Contact Information
Primary
Gavin J Murphy, FRCS, MD, MBChB, BSc
gjm19@le.ac.uk
0116 258 3054
Backup
Ann Cheng, MBChB, MSc
ann.cheng1@nhs.net
Time Frame
Start Date: 2024-05-20
Estimated Completion Date: 2026-02
Participants
Target number of participants: 100
Treatments
Active_comparator: Hypothermic Cardiopulmonary Bypass
Patients allocated to this arm will undergo standard care for coronary artery bypass grafting and/or valve surgery with mild hypothermia during CPB.
Active_comparator: Normothermic Cardiopulmonary Bypass
Patients allocated to this arm will undergo intervention care for coronary artery bypass grafting and/or valve surgery with normothermia hypothermia during CPB.
Related Therapeutic Areas
Sponsors
Collaborators: Hull University Teaching Hospitals NHS Trust, King's College Hospital NHS Trust, Royal Brompton & Harefield NHS Foundation Trust, Sheffield Teaching Hospitals NHS Foundation Trust, University Hospitals Bristol and Weston NHS Foundation Trust, University Hospital Plymouth NHS Trust, University Hospitals, Leicester, NHS National Waiting Times Centre Board, Oxford University Hospitals NHS Trust
Leads: University of Leicester

This content was sourced from clinicaltrials.gov