An interventional study of Hypothermic Cardiopulmonary Bypass and Normothermic Cardiopulmonary Bypass in Ischemic Heart Disease, Valvular Heart Disease and Cardiovascular Diseases, sponsored by University of Leicester. Recruiting at 11 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-21.
Sponsored by University of Leicester · Not applicable, Interventional, and Treatment
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.
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.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's planned enrollment of 100 is close to the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
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Participants may enter the trial if all of the following apply
EXCLUSION CRITERIA
Participants may not enter the trial if any of the following apply:
Patients allocated to this arm will undergo standard care for coronary artery bypass grafting and/or valve surgery with mild hypothermia during CPB.
Procedure: Hypothermic Cardiopulmonary Bypass
Patients allocated to this arm will undergo intervention care for coronary artery bypass grafting and/or valve surgery with normothermia hypothermia during CPB.
Procedure: Normothermic Cardiopulmonary Bypass
Mild hypothermia (between 32 - 35 °C) during cardiopulmonary bypass
Normothermia (active maintenance of temperature between 36.5 °C to 37.5°C; no active cooling below 36.5 °C) during cardiopulmonary bypass
Total number of participants recruited over a 6 month period
The target recruitment rate is 1 participant per week per centre. The feasibility trial will be considered positive if 80% of target met, together with outcome 2.
Time frame: 6 months
Adherence rate to allocation
The feasibility trial will be considered positive if 74%\* of target adherence to trial allocation is met, together with outcome 1. \*74% is derived from 80% of target adherence of 92% as per Warm Heart Study
Time frame: 6 months
Incidence of 6-week composite endpoint of Major Adverse Cardiac and Cerebrovascular Events (MACCE)
MACCE is defined as any post-operative death, stroke, new intra-aortic balloon pump insertion, new renal replacement therapy, re-operation and major bleeding in this feasibility trial.
Time frame: 6 weeks
Incidence of deep sternal wound infection, with or without treatment
Deep sternal wound infection is defined with at least one of the following criteria: (I) an organism is isolated from culture of mediastinal tissue or fluid (II) evidence of mediastinitis seen intraoperatively (III) presence of chest pain, sternal instability, or fever (\> 38 °C), and purulent drainage from the mediastinum or isolation of organism present in a blood culture or from the mediastinal area.
Time frame: 6 weeks
Incidence of all adverse events
Composite of all reported adverse events. Examples of adverse events include: low cardiac output, suspected myocardial infarction, arrhythmias, infections, haemorrhage, and pulmonary embolus.
Time frame: 6 weeks
Critical care length of stay
Number of days a participant is admitted in cardiac critical care unit
Time frame: 6 weeks
Post-operative length of stay
Number of days a participant is an in-patient after index operation
Time frame: 6 weeks
Frequency of post-discharge healthcare resource utilisation
Number of visits to general practitioner (GP) and/or hospital, either district general hospital or tertiary hospital, will be recorded via HealthBitⓇ.
Time frame: 6 weeks
Quality of life post-operation: Medical Outcomes Study Short-Form 36 (SF-36)
Quality of life questionnaire (SF-36) will administered before surgery and at 6-week follow up
Time frame: 6 weeks
Quality of life post-operation: European Quality of Life-5 Dimensions (EQ-5D)
Quality of life questionnaire (EQ-5D) will administered before surgery and at 6-week follow up
Time frame: 6 weeks
Quality of life post-operation: World Health Organisation Disability Assessment Schedule (WHODAS)
Quality of life questionnaire (WHODAS) will administered before surgery and at 6-week follow up
Time frame: 6 weeks
Clinical Frailty Scale (CFS) post-operation
Clinical Frailty Scale will be recorded before surgery and at 6-week follow up
Time frame: 6 weeks
Data completeness
Data recorded on HealthBitⓇ will be assessed for percentage of completion
Time frame: 6 months
Attrition rate
For ascertainment of the primary outcome and for planning of future large-scale study
Time frame: 6 months
User satisfaction of ResearchApp
Participants will be invited to complete optional survey on user satisfaction of ResearchApp
Time frame: 6 months
Plan to share: Yes — Fully anonymised individual participant data can be made available on request for future studies with ethics approval.
Supporting information: Study protocol, Csr
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University of Leicester