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Comparing body temperature management during heart surgery

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

Not applicable Interventional University of Leicester · NCT05996120

This study is testing whether managing body temperature differently during heart surgery can lead to better outcomes for patients.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment100 (estimated)
Ages18 Years and up
SexAll
SponsorUniversity of Leicester Academic / other
Locations11 sites (Leicester, Leicestershire and 10 other locations)
Trial IDNCT05996120 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are adult patients aged 18 and older scheduled for coronary artery bypass surgery or valve replacement/repair with a EuroSCORE II of 2 or higher.

Not a fit: Patients undergoing emergency surgeries, off-pump cardiac surgeries, or those participating in other interventional trials may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved safety and outcomes for patients undergoing heart surgery by identifying the best temperature management strategy during CPB.

How similar studies have performed: Previous studies have shown mixed results regarding temperature management during CPB, making this approach both relevant and necessary for further investigation.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Leicester, Leicestershire and 10 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Ischemic Heart DiseaseValvular Heart DiseaseCardiovascular DiseasesSurgery-Complicationscardiopulmonary bypasshypothermiamyocardial protectionneurologic protection
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.