Condition: Ischemic Heart Disease · Valvular Heart Disease · Cardiovascular Diseases · Sponsor: University of Leicester
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 compar…
This description comes directly from the study's public registry record.
Gavin J Murphy, FRCS, MD, MBChB, BSc · 0116 258 3054 · gjm19@le.ac.uk
Ann Cheng, MBChB, MSc · ann.cheng1@nhs.net
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| Glenfield Hospital, University Hospitals of Leicester NHS Trust | Leicester, Leicestershire, United Kingdom | Recruiting |
| Blackpool Victoria Hospital, Blackpool Teaching Hospitals NHS Foundation Trust | Blackpool, United Kingdom | Not Yet Recruiting |
| University Hospitals Bristol and Weston NHS Foundation Trust | Bristol, United Kingdom | Recruiting |
| Castle Hill Hospital, Hull University Teaching Hospitals NHS Trust | Cottingham, United Kingdom | Recruiting |
| Golden Jubilee National Hospital, NHS Golden Jubilee | Glasgow, United Kingdom | Recruiting |
| King's College Hospital, King's College Hospital NHS Foundation Trust | London, United Kingdom | Recruiting |
| Royal Brompton Hospital, Guy's and St Thomas' NHS Foundation Trust | London, United Kingdom | Not Yet Recruiting |
| Harefield Hospital, Guy's and St Thomas' NHS Foundation Trust | London, United Kingdom | Not Yet Recruiting |
| John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust | Oxford, United Kingdom | Recruiting |
| Derriford Hospital, Plymouth University Hospitals NHS Trust | Plymouth, United Kingdom | Recruiting |
| Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation Trust | Sheffield, United Kingdom | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05996120