Comparing body temperature management during heart surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the feasibility of conducting a multicenter randomized controlled trial comparing hypothermic and normothermic cardiopulmonary bypass (CPB) during adult cardiac surgeries. It will assess recruitment and delivery methods in the UK, utilizing a novel remote data capture system for data collection. The study seeks to gather pilot data to inform a larger trial that will determine the optimal temperature management during CPB for improved patient outcomes.

Why it matters

Who can join: the full rules

INCLUSION CRITERIA

Participants may enter the trial if all of the following apply

1. Adult patients (≥ 18 years) scheduled for coronary artery bypass surgery and/or valve replacement/ repair, either in the elective or urgent setting.
2. European System for Cardiac Operative Risk Evaluation (EuroSCORE) II of 2 or higher.
3. Able to understand and communicate to provide informed consent.
4. Able to read and understand the English language.

EXCLUSION CRITERIA

Participants may not enter the trial if any of the following apply:

1. Patients undergoing coronary artery bypass surgery in combination with other procedures including cardiac or vascular procedures that require deep hypothermic arrest.
2. Patients undergoing emergency or salvage surgery.
3. Patients undergoing off-pump cardiac surgery.
4. Patients who are participating in another interventional trial.
5. Unable to provide informed consent.

Where it's running

• Glenfield Hospital, University Hospitals of Leicester NHS Trust
  Leicester, Leicestershire, United Kingdom 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
• John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust
  Oxford, United Kingdom Recruiting

Study contacts

• Study coordinator: Gavin J Murphy, FRCS, MD, MBChB, BSc
• Email: gjm19@le.ac.uk
• Phone: 0116 258 3054

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.