Study on Optimal Temperature During Cardiopulmonary Bypass (THERMIC-4)

Launched by UNIVERSITY OF LEICESTER · Aug 10, 2023

Keywords

ClinConnect Summary

The THERMIC-4 trial is investigating whether keeping patients at normal body temperature (normothermia) during heart surgery is safer than cooling them down (hypothermia) using a heart-lung machine, which helps maintain blood flow and oxygen to the body while the heart is being operated on. Historically, many surgeons have used hypothermia because it was believed to protect the brain and organs by lowering their oxygen needs. However, some recent studies suggest that normothermia could be a safe alternative. This trial will involve 100 adults at 10 cardiac surgery centers in the UK, aiming to see if patients can be successfully recruited and if the study can be carried out effectively.

To be eligible, participants must be adults aged 18 and older who are scheduled for coronary artery bypass surgery or valve repair, have a certain risk score indicating they need surgery, and can understand and give consent in English. Participants will be asked to complete quality of life surveys and will help gather important data that could lead to larger future studies. Overall, the findings from this trial will help determine the best temperature management approach during heart surgery, which could improve patient outcomes.

Gender

ALL

Eligibility 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.