Active not recruitingNAINTERVENTIONAL

Sedation, Temperature and Pressure After Cardiac Arrest and Resuscitation

This study, called STEPCARE, is for people who have been brought back to life after their heart suddenly stopped, but are still unconscious. We are looking at three main things to help recovery: how much calming medicine to give, how to best control body temperature, and what blood pressure level is ideal. Patients will be divided into different groups, and each group will receive a specific level of calming medicine, temperature control, and blood pressure target. The aim is to find the best combination of care to help patients survive and recover well over the long term. We'll check in with patients 30 days and 6 months after the heart stop to see how they're doing.

At a glance

Status

Active not recruiting

Phase

Sponsor

Region Skane

Enrolment target

3,500

Start

17 Aug 2023

Estimated completion

01 Mar 2027

Cardiac Arrest With Successful Resuscitation Hypoxia, Brain

What is this study about?

When someone's heart stops suddenly, it's called a cardiac arrest. If doctors are able to get the heart beating again, it's a huge step forward. However, some people remain unconscious afterwards. This study, called STEPCARE, is designed to find the best ways to care for these patients in the intensive care unit.

The research focuses on three key areas of care. Firstly, it looks at how much calming medicine (sedation) patients should receive – some will get a lot, and some will get very little. Secondly, it investigates how best to manage body temperature, including whether using special devices to control fever helps. Finally, the study examines what blood pressure level is most effective for recovery. By testing different approaches in these areas, researchers hope to improve patient outcomes.

The main goal of this study is to discover which combinations of these treatments help patients survive for longer and recover better. Understanding the best approach to sedation, temperature control, and blood pressure management could significantly improve the chances of a good recovery for future patients who experience a cardiac arrest.

Key takeaways

This study compares different ways to care for unconscious patients after a heart stop.
It focuses on calming medicine, body temperature, and blood pressure levels.
The goal is to find the best care to help patients survive and recover well.
Participation involves being assigned to different care groups, not choosing one.
Follow-up checks will happen at 30 days and 6 months after the heart stop.

Who may be eligible?

This study is for adults, aged 18 or older, who have had a sudden heart stop outside of the hospital and have been successfully brought back to life, but are still unconscious. You would need to be able to receive full intensive care without any restrictions.

You wouldn't be able to join if you were already on a special heart-lung machine (ECMO) before the study, if you are pregnant, or if there's a strong suspicion you have bleeding inside your head. Also, if your heart stopped due to a severe injury or significant bleeding, or if you've already been part of this specific study before, you wouldn't be included.

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.

Did your heart stop suddenly outside a hospital?
Did your heart start beating again, but you're still unconscious?
Are you 18 years old or older?
Are you able to receive full intensive care without any limitations?
Were you NOT on a special heart-lung machine (ECMO) before the study?

Answer every question to see your result.

What does participation involve?

If you are eligible and agree to take part, you would be randomly assigned to different care groups for your calming medicine, body temperature control, and blood pressure targets. This means you wouldn't choose which group you are in. These specific care approaches would be managed by your doctors and nurses while you are in the intensive care unit. Once you leave the hospital, there will be two follow-up checks. The first will be about 30 days after your heart stop, and the second around 6 months later. These check-ups will help us understand how you are recovering and your overall health.

Potential risks and benefits

While this study aims to find better ways to care for patients, it's important to know that there might not be a direct benefit to you personally. However, the information gained could help many future patients. There are no new medications being tested, but different established treatment approaches are being compared. Your care team will closely monitor you throughout for any unexpected issues. You or your legal representative have the right to withdraw from the study at any time without affecting your medical care.

Locations (56)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Nepean Hospital
Verified postcode
Kingswood, Australia
Liverpool Hospital
Verified postcode
Liverpool, Australia
Royal North Shore Hospital
Verified postcode
Sydney, Australia
St George Hospital
Verified postcode
Sydney, Australia
The Sutherland Hospital
Verified postcode
Sydney, Australia
Princess Alexandra Hospital
Verified postcode
Brisbane, Australia
The Prince Charles Hospital
Verified postcode
Brisbane, Australia
Austin Hospital
Verified postcode
Melbourne, Australia
HUB Hôpital Erasme
Verified postcode
Brussels, Belgium
Ghent University Hospital
Verified postcode
Ghent, Belgium
Ziekenhuis Oost-Limburg Hospital
Verified postcode
Lanaken, Belgium
North Estonia Medical Centre, Tallinn
Verified postcode
Tallinn, Estonia

Common questions

What is a cardiac arrest?

A cardiac arrest is when your heart suddenly stops beating effectively, causing you to collapse and become unconscious.

What does 'unconscious' mean in this study?

It means a patient is not awake enough to follow simple commands, or they are on a breathing machine and need calming medicine because they are agitated after their heart has started beating again.

Will I get special medicine?

No, the study isn't testing new medicines. It's looking at different ways to use calming medicines, manage temperature, and control blood pressure that are already part of standard care.

Why is it important to control body temperature?

Controlling body temperature carefully can help protect the brain and other organs after a heart stop.

How long will I be in the study?

The main part of the care being studied happens while you are in the intensive care unit. After that, there will be follow-up checks at 30 days and 6 months after your heart stopped.