Clinical trial NCT05996120: Study on Optimal Temperature During Cardiopulmonary Bypass (THERMIC-4)
Official title: Normothermic Versus Hypothermic Cardiopulmonary Bypass in Adult Cardiac Surgery: a Multicentre Feasibility Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ischemic Heart Disease
Valvular Heart Disease
Cardiovascular Diseases
Surgery-Complications
Keywords: cardiopulmonary bypass
hypothermia
myocardial protection
neurologic protection
Lead sponsor: University of Leicester
Sponsor class: OTHER
Collaborators: name: NHS National Waiting Times Centre Board
name: Sheffield Teaching Hospitals NHS Foundation Trust
name: Oxford University Hospitals NHS Trust
name: Hull University Teaching Hospitals NHS Trust
name: University Hospitals Bristol and Weston NHS Foundation Trust
name: University Hospitals, Leicester
name: Royal Brompton & Harefield NHS Foundation Trust
name: King's College Hospital NHS Trust
name: University Hospital Plymouth NHS Trust
First posted: 2023-08-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel group, open label, statistician blinded, multicentre, randomised controlled feasibility trial.
Primary purpose: TREATMENT

Brief summary: 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 comparator) during cardiopulmonary bypass in cardiac surgery. This study will also test the ability of the Cardiothoracic Interdisciplinary Research Network (CIRN), a trainee-led research collaborative, to collect pilot data on Major Adverse Cardiac and Cerebrovascular Events (MACCE) using a regulation-approved electronic application HealthBitⓇ. Participants will also be asked to complete quality of life surveys. The results of this study will subsequently inform a large, adequately powered randomised controlled trial for optimal temperature management during CPB.

Detailed description: Primary Objective

To assess the feasibility of trial recruitment and delivery to target in the United Kingdom of a multicentre randomised controlled trial on normothermia versus hypothermia during cardiopulmonary bypass in adult cardiac surgery.

Secondary Objective

To assess the feasibility of conducting a multicentre randomized controlled trial (RCT) using a novel Good Clinical Practice (GCP) approved remote data capture as the primary trial database alongside analysis of routinely collected healthcare data.

To obtain pilot data, undertaken by the Cardiothoracic Interdisciplinary Research Network (CIRN), to inform a subsequent large, adequately powered RCT for optimal temperature management during CPB.

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.

Primary outcomes:
measure: Total number of participants recruited over a 6 month period
timeFrame: 6 months
measure: Adherence rate to allocation
timeFrame: 6 months
Secondary outcomes:
measure: Incidence of 6-week composite endpoint of Major Adverse Cardiac and Cerebrovascular Events (MACCE)
timeFrame: 6 weeks
measure: Incidence of deep sternal wound infection, with or without treatment
timeFrame: 6 weeks
measure: Incidence of all adverse events
timeFrame: 6 weeks
measure: Critical care length of stay
timeFrame: 6 weeks
measure: Post-operative length of stay
timeFrame: 6 weeks
measure: Frequency of post-discharge healthcare resource utilisation
timeFrame: 6 weeks
measure: Quality of life post-operation: Medical Outcomes Study Short-Form 36 (SF-36)
timeFrame: 6 weeks
measure: Quality of life post-operation: European Quality of Life-5 Dimensions (EQ-5D)
timeFrame: 6 weeks
measure: Quality of life post-operation: World Health Organisation Disability Assessment Schedule (WHODAS)
timeFrame: 6 weeks
measure: Clinical Frailty Scale (CFS) post-operation
timeFrame: 6 weeks
Other outcomes:
measure: Data completeness
timeFrame: 6 months
measure: Attrition rate
timeFrame: 6 months
measure: User satisfaction of ResearchApp
timeFrame: 6 months
Locations:
city: Leicester
country: United Kingdom
facility: Glenfield Hospital, University Hospitals of Leicester NHS Trust
state: Leicestershire
city: Blackpool
country: United Kingdom
facility: Blackpool Victoria Hospital, Blackpool Teaching Hospitals NHS Foundation Trust
city: Bristol
country: United Kingdom
facility: University Hospitals Bristol and Weston NHS Foundation Trust
city: Cottingham
country: United Kingdom
facility: Castle Hill Hospital, Hull University Teaching Hospitals NHS Trust
city: Glasgow
country: United Kingdom
facility: Golden Jubilee National Hospital, NHS Golden Jubilee
city: London
country: United Kingdom
facility: King's College Hospital, King's College Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: Royal Brompton Hospital, Guy's and St Thomas' NHS Foundation Trust
city: London
country: United Kingdom
facility: Harefield Hospital, Guy's and St Thomas' NHS Foundation Trust
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust
city: Plymouth
country: United Kingdom
facility: Derriford Hospital, Plymouth University Hospitals NHS Trust
city: Sheffield
country: United Kingdom
facility: Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation Trust
Study officials:
References: