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RecruitingNAINTERVENTIONAL

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

This study, called THERMIC-4, is looking into the best way to manage body temperature during open-heart surgery for people with heart conditions. When patients have heart surgery, a machine called a heart-lung machine (cardiopulmonary bypass) keeps blood flowing through their body. Traditionally, patients are cooled down during this time to protect organs. However, some doctors believe keeping the body at a normal temperature might be just as safe, or even better. This study will involve 100 adult patients from 10 different hospitals across the UK. We want to see if it's possible to successfully run a larger study comparing these two temperature approaches. We'll also collect early information on how patients recover and their quality of life.

At a glance

Status
Recruiting
Phase
NA
Sponsor
University of Leicester
Enrolment target
100
Start
20 May 2024
Estimated completion
01 Feb 2026

What is this study about?

When you have certain types of heart surgery, doctors use a special machine called a heart-lung machine. This machine takes over the work of your heart and lungs, making sure your body and organs still get the blood and oxygen they need during the operation. For a long time, it's been common practice to cool down your body during this process. This is because some doctors believe that a cooler body needs less oxygen, which could protect your brain and other organs.

However, in recent years, some doctors have started to question if cooling is always necessary. They believe that keeping your body at a normal temperature might be just as safe, and potentially even better, for some patients. Despite these questions, most heart surgeons in the UK still choose to cool patients down. This study wants to find out if keeping your body at a normal temperature during heart surgery is a safe and good alternative to cooling it down.

This study is the first step in answering that big question. We will involve 100 adult patients across 10 different hospitals in the UK. Half of these patients will be kept at a normal body temperature during their surgery, and the other half will be cooled down as is traditionally done. Importantly, this initial study isn't designed to give a final answer on which method is best. Instead, it's a 'feasibility' study which means we want to see if it's practical to run a much bigger study later on. We'll check how easy it is to invite patients to take part, and how well we can stick to the different temperature plans. We'll also gather early information on how patients recover and how they feel after the surgery, including their quality of life.

Key takeaways

  • This study compares keeping body temperature normal versus cooling during heart surgery.
  • It’s a first step to see if a larger study on temperature management can be done.
  • 100 adults having specific heart surgeries will take part across 10 UK hospitals.
  • You'll be randomly assigned to one of the two temperature approaches.
  • We'll collect information on your recovery and quality of life after surgery.

Who may be eligible?

To take part in this study, you need to be an adult (18 years or older) who is scheduled to have heart surgery. This type of surgery often involves repairing or replacing heart valves, or bypass surgery for blocked heart arteries. This includes surgeries planned in advance or those that need to happen fairly soon, but not immediate emergencies. You also need to be able to understand and speak English to give your permission to join and complete surveys.

There are some reasons why you wouldn't be able to join the study. For example, if your surgery is an extreme emergency, or if you are having a very complex type of heart surgery that already requires extreme cooling of the body. You also couldn't take part if you're already involved in another similar medical study or if your heart surgery won't be using the heart-lung machine.

Quick self-check
  • Are you 18 years old or older?
  • Are you having certain types of planned heart surgery (like bypass or valve repair/replacement)?
  • Can you understand and speak English?
  • Are you able to agree to take part in the study?
  • Are you NOT having emergency surgery or another very complex type of heart surgery not using the heart-lung machine?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you choose to take part in this study, you would be randomly assigned to one of two groups: either your body temperature will be kept normal during your heart surgery, or it will be cooled down, which is the more traditional approach. Both treatments are standard practice and will be overseen by your medical team.

After your surgery, we will collect information about your health using a special electronic app. You will also be asked to complete some short questionnaires about your quality of life at different times after your surgery.

Potential risks and benefits

Taking part in this study may or may not directly benefit you, but the information we learn could help improve future care for people having heart surgery. Both temperature approaches used in this study are already common practice, so your medical team believes either approach is suitable for you. As with any surgery, there are risks involved. We will carefully watch for any serious health problems and collect information on how you recover. You are always free to leave the study at any time, for any reason, without it affecting your medical care.

Locations (11)

  • Glenfield Hospital, University Hospitals of Leicester NHS Trust
    Leicester, United Kingdom· Recruiting
  • Blackpool Victoria Hospital, Blackpool Teaching Hospitals NHS Foundation Trust
    Blackpool, United Kingdom· Not yet recruiting
  • University Hospitals Bristol and Weston NHS Foundation Trust
    Bristol, United Kingdom· Recruiting
  • Castle Hill Hospital, Hull University Teaching Hospitals NHS Trust
    Cottingham, United Kingdom· Recruiting
  • Golden Jubilee National Hospital, NHS Golden Jubilee
    Glasgow, United Kingdom· Recruiting
  • King's College Hospital, King's College Hospital NHS Foundation Trust
    London, United Kingdom· Recruiting
  • Royal Brompton Hospital, Guy's and St Thomas' NHS Foundation Trust
    London, United Kingdom· Not yet recruiting
  • Harefield Hospital, Guy's and St Thomas' NHS Foundation Trust
    London, United Kingdom· Not yet recruiting
  • John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust
    Oxford, United Kingdom· Recruiting
  • Derriford Hospital, Plymouth University Hospitals NHS Trust
    Plymouth, United Kingdom· Recruiting
  • Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation Trust
    Sheffield, United Kingdom· Recruiting

Common questions

What is a heart-lung machine?

It's a machine used during heart surgery that temporarily takes over the job of your heart and lungs, keeping blood and oxygen flowing around your body.

What's the difference between 'hypothermia' and 'normothermia'?

Hypothermia means your body is cooled below normal temperature. Normothermia means your body is kept at a normal temperature. Both are used during heart surgery.

Will I know which temperature group I'm in?

Because this is a 'randomised' study, you will be assigned to one group by chance. Your medical team will know, but the study will focus on comparing the overall results.

What is a 'feasibility study'?

It's a first step to see if a bigger study is possible. We want to check if it's practical to recruit enough patients and collect the right information before committing to a larger trial.

What happens if I change my mind about participating?

You are free to withdraw from the study at any time without giving a reason, and it will not affect your medical care.

How to find out more

Gavin J Murphy, FRCS, MD, MBChB, BSc

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Study on Optimal Temperature During Cardiopulmonary Bypass (…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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