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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Hypothermic Cardiopulmonary Bypass
  Mild hypothermia (between 32 - 35 °C) during cardiopulmonary bypass
• Процедура Normothermic 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

Первичные конечные точки

• Total number of participants recruited over a 6 month period [Срок оценки: 6 months]
• Adherence rate to allocation [Срок оценки: 6 months]

Вторичные конечные точки (10)

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

Критерии участия

Критерии включения

Participants may enter the trial if all of the following apply

• Adult patients (≥ 18 years) scheduled for coronary artery bypass surgery and/or valve replacement/ repair, either in the elective or urgent setting.
• European System for Cardiac Operative Risk Evaluation (EuroSCORE) II of 2 or higher.
• Able to understand and communicate to provide informed consent.
• Able to read and understand the English language.

Критерии исключения

Participants may not enter the trial if any of the following apply:

• Patients undergoing coronary artery bypass surgery in combination with other procedures including cardiac or vascular procedures that require deep hypothermic arrest.
• Patients undergoing emergency or salvage surgery.
• Patients undergoing off-pump cardiac surgery.
• Patients who are participating in another interventional trial.
• Unable to provide informed consent.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Великобритания · 11 центров

• Glenfield Hospital, University Hospitals of Leicester NHS Trust — Leicester
• Blackpool Victoria Hospital, Blackpool Teaching Hospitals NHS Foundation Trust — Blackpool
• University Hospitals Bristol and Weston NHS Foundation Trust — Bristol
• Castle Hill Hospital, Hull University Teaching Hospitals NHS Trust — Cottingham
• Golden Jubilee National Hospital, NHS Golden Jubilee — Glasgow
• King's College Hospital, King's College Hospital NHS Foundation Trust — London
• Royal Brompton Hospital, Guy's and St Thomas' NHS Foundation Trust — London
• Harefield Hospital, Guy's and St Thomas' NHS Foundation Trust — London
• … и ещё 3 центра

Идентификаторы

NCT: NCT05996120 · 0910 · IRAS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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