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

Not Applicable

Recruiting

• Conditions: Ischemic Heart Disease; Valvular Heart Disease; Cardiovascular Diseases; Surgery-Complications

• Registration Number: NCT05996120
• Lead Sponsor: University of Leicester

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-7-2
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

INCLUSION CRITERIA<br><br>Participants may enter the trial if all of the following apply<br><br> 1. Adult patients (= 18 years) scheduled for coronary artery bypass surgery and/or<br> valve replacement/ repair, either in the elective or urgent setting.<br><br> 2. European System for Cardiac Operative Risk Evaluation (EuroSCORE) II of 2 or higher.<br><br> 3. Able to understand and communicate to provide informed consent.<br><br> 4. Able to read and understand the English language.<br><br>EXCLUSION CRITERIA<br><br>Participants may not enter the trial if any of the following apply:<br><br> 1. Patients undergoing coronary artery bypass surgery in combination with other<br> procedures including cardiac or vascular procedures that require deep hypothermic<br> arrest.<br><br> 2. Patients undergoing emergency or salvage surgery.<br><br> 3. Patients undergoing off-pump cardiac surgery.<br><br> 4. Patients who are participating in another interventional trial.<br><br> 5. Unable to provide informed consent.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total number of participants recruited over a 6 month period;Adherence rate to allocation

Secondary Outcome Measures

Name	Time	Method
Incidence of 6-week composite endpoint of Major Adverse Cardiac and Cerebrovascular Events (MACCE);Incidence of deep sternal wound infection, with or without treatment;Incidence of all adverse events;Critical care length of stay;Post-operative length of stay;Frequency of post-discharge healthcare resource utilisation;Quality of life post-operation: Medical Outcomes Study Short-Form 36 (SF-36);Quality of life post-operation: European Quality of Life-5 Dimensions (EQ-5D);Quality of life post-operation: World Health Organisation Disability Assessment Schedule (WHODAS);Clinical Frailty Scale (CFS) post-operation