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

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.

Conditions

• Ischemic Heart Disease
• Valvular Heart Disease
• Cardiovascular Diseases
• Surgery-Complications

Interventions

PROCEDURE

Hypothermic Cardiopulmonary Bypass

Mild hypothermia (between 32 - 35 °C) during cardiopulmonary bypass

PROCEDURE

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

Sponsors & Collaborators

• NHS National Waiting Times Centre Board

  collaborator OTHER

• Sheffield Teaching Hospitals NHS Foundation Trust

  collaborator OTHER

• Oxford University Hospitals NHS Trust

  collaborator OTHER

• Hull University Teaching Hospitals NHS Trust

  collaborator OTHER_GOV

• University Hospitals Bristol and Weston NHS Foundation Trust

  collaborator OTHER

• University Hospitals, Leicester

  collaborator OTHER

• Royal Brompton & Harefield NHS Foundation Trust

  collaborator OTHER

• King's College Hospital NHS Trust

  collaborator OTHER

• University Hospital Plymouth NHS Trust

  collaborator OTHER

• University of Leicester

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-05-20

Primary Completion

2025-11-30

Completion

2026-02-28

Countries

• United Kingdom

Study Locations