RecruitingNAINTERVENTIONAL

Fever Control Using External Cooling in Mechanically Ventilated Patients With Septic Shock

This study aims to find the best way to handle fever in critically ill patients who have septic shock and are using a breathing machine. Septic shock is a life-threatening condition caused by a severe infection, where the body’s response to infection damages its own tissues and organs. We know fever is common here, but it's unclear if it's better to let it continue or actively cool the patient. In a previous smaller study, cooling seemed to help organs recover and reduced early deaths. This new, larger study will carefully compare two approaches: letting the fever go on its own, or using external cooling methods to keep the body's temperature normal for a short period. We'll be looking closely at how many people survive after 60 days to see which method is more effective.

At a glance

Status

Recruiting

Phase

Sponsor

Centre Hospitalier Intercommunal Creteil

Enrolment target

820

Start

01 Oct 2022

Estimated completion

01 Dec 2026

Septic Shock

What is this study about?

When someone has a serious infection that leads to septic shock, their body temperature often goes up, causing a fever. Septic shock is a very serious condition where the body's reaction to an infection causes very low blood pressure and organ damage. Patients with septic shock are usually very unwell and often need help breathing with a machine (mechanical ventilation).

Doctors don't fully agree on the best way to manage fever in these patients. Some believe fever helps fight infection, while others think it puts extra stress on the body and organs that are already struggling. A previous small study suggested that carefully cooling patients to bring their temperature down to normal might help their organs recover better and could improve their chances of survival. However, that study wasn't big enough to give a final answer about survival.

This new, larger study aims to get a clearer picture. We want to see if actively cooling patients to bring their fever down to a normal temperature is better than letting the fever run its course naturally. By comparing these two approaches, we hope to find out which method helps more patients with septic shock recover and survive, potentially improving care for very sick people in the future.

Key takeaways

The study compares two ways to manage fever in very sick patients with septic shock.
It aims to find out if cooling patients to a normal temperature improves survival.
Patients will already be on a breathing machine and have a fever.
Participation involves either regular care or careful cooling for 48 hours.
The main goal is to see if one method helps more people survive after 60 days.
Study approval is based on a doctor's belief it's safe for the patient.

Who may be eligible?

This study is looking for adults aged 18 or older who are in hospital with septic shock and need help breathing using a machine. They must have a fever (body temperature above 38.3°C) and be receiving medicines for sedation or pain. It's also important they are already being treated for their infection, for example with antibiotics.

There are also some reasons why someone might not be able to join. For example, if they've recently had a heart attack or a serious brain injury, or have very severe skin burns. People who are pregnant, under legal guardianship, or already taking part in another similar study that looks at survival would also not be able to join this one.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have septic shock and need a breathing machine?
Do you currently have a body temperature above 38.3°C?
Are you receiving medicines for sedation or pain?
Are you being treated for an infection (e.g., with antibiotics)?

Answer every question to see your result.

What does participation involve?

If you or your loved one takes part in this study, you would be randomly assigned to one of two groups, like flipping a coin. One group would receive the usual care where their fever is simply monitored. The other group would receive special external cooling to bring their body temperature down to normal and keep it there for about 48 hours. This cooling might involve special blankets or pads placed on the skin.

Doctors and nurses would closely monitor the patient's condition, temperature, and other vital signs throughout their stay in the intensive care unit. The study would primarily involve observing the patient's progress and how they respond to the assigned fever management strategy. The main outcome we're looking at is survival up to 60 days after joining the study, so there would be follow-up to check on the patient's health during that period.

Potential risks and benefits

Taking part in any study has possible benefits and risks. For this study, potential benefits might include improved organ recovery and a better chance of survival, particularly if cooling proves to be helpful. However, there's also a chance that cooling might not be beneficial for everyone, or could even carry its own minor risks, which would be carefully monitored by the medical team. You and your family always have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (33)

CHU Amiens
Verified postcode
Amiens, France· Recruiting
CHU Angers
Verified postcode
Angers, France· Recruiting
CH Victor Dupouy
Verified postcode
Argenteuil, France· Recruiting
Hôpital Nord Franche Comté
Verified postcode
Belfort, France· Recruiting
CH Cholet
Verified postcode
Cholet, France· Recruiting
Centre hospitalier intercommunal de Créteil
Verified postcode
Créteil, France· Recruiting
Hôpital Henri Mondor
Verified postcode
Créteil, France· Active not recruiting
CHD Dijon
Verified postcode
Dijon, France· Recruiting
CHU Grenoble
Verified postcode
Grenoble, France· Recruiting
GH Est Francilien
Verified postcode
Jossigny, France· Recruiting
CHD Vendée
Verified postcode
La Roche-sur-Yon, France· Recruiting
CHU Kremlin Bicetre
Verified postcode
Le Kremlin-Bicêtre, France· Active not recruiting

Common questions

What is septic shock?

Septic shock is a life-threatening condition caused by a severe infection where the body's reaction harms its own organs, leading to very low blood pressure.

Why is fever a concern in septic shock?

Fever can make the body use more oxygen, which is a problem for organs already struggling, though fever also helps fight infection.

How does 'external cooling' work?

External cooling usually involves using special blankets or pads that are placed on the skin to gently lower the body's temperature towards normal.

Will I or my loved one still get full medical care if we join?

Yes, all patients in the study will receive the highest standard of medical care for their septic shock and other conditions.

How long does the cooling treatment last if assigned to that group?

If assigned to the cooling group, the external cooling treatment would typically be used for about 48 hours.

How to find out more

Frédérique SCHORTGEN, MD

frederique.schortgen@chicreteil.fr 01 57 02 34 11 Official trial record

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