For patients and relatives

What is cardiac arrest?

Cardiac arrest is a sudden medical condition that occurs when the heart stops beating, sometimes caused by a disturbance in the heart’s electrical activity. When the heart’s pumping ability is disrupted, it cannot pump blood to the brain. Consequently, a person stops breathing and loses consciousness. Immediate intervention is needed by people who happen to be present at the time or by ambulance staff when they arrive – they may perform compressions of the chest and use techniques for artificial breathing to help maintain heart and lung function. Without prompt treatment, cardiac arrest is usually fatal.

What is the purpose of this study?

The STEPCARE study aims to determine the optimal intensive care treatment for the patient after arrival in hospital. In this study we will be comparing strategies for the use of sedatives, for controlling fever and for blood pressure management. The most favorable way to apply these interventions has yet to be discovered. The STEPCARE trial intends to ascertain how these treatment approaches can best be implemented to give cardiac arrest patients the optimal chance of a good recovery, improving chances of survival and preventing neurological damage. 

Who conducts the study?

The STEPCARE-project is a growing international network with collaborating centers studying treatments after cardiac arrest – the network has already completed three important scientific studies that have impacted the improvement of clinical care. The research network now includes hospitals in Europe, Australia, New Zealand, and Asia. Each country conducting the study will have a national coordinating investigator and a principal investigator at each participating hospital.

Which interventions might I receive?

The three interventions that will be studied are the strategies for the use of sedatives, control of body temperature and for blood pressure, as described below. The interventions will be allocated through randomization to ensure objectivity and unbiasedness when comparing and evaluating the treatments. Participants will not be informed of which treatment they have received. 
Participants in the study will be randomized to one treatment from each of the three following strategies:
Sedation Management
There is an equal (50/50) chance of being allocated to:
   - Deep sedation
   - Minimal sedation
Fever Control
There is an equal (50/50) chance of being allocated to:
   - Fever treatment with a cooling device
   - Fever treatment without a cooling device
Blood Pressure Control
There is an equal (50/50) chance of being allocated to:
   - A lower blood pressure target
   - A higher blood pressure target

What are the potential risks and benefits?

As this study will adapt existing treatments used in clinical care, the risks involved are minimal and similar to those encountered in usual clinical care. Potential side effects may arise in any clinical trial. Despite all precautions, it is possible to experience side effects from participating in the study. 
The optimal approaches to sedation and temperature management and the best blood pressure target in cardiac arrest patients receiving intensive care treatment are uncertain. Deep sedation may prevent seizures or help the brain rest, but there is also a risk of developing pneumonia or agitation when waking up. Using a cooling device may prevent fever but may cause side effects such as shivering. The optimal blood pressure target in cardiac arrest patients treated with intensive care is unknown. Patients’ blood pressure can be adjusted by changing the doses of intravenous medications. A higher dose of medicine may be required to achieve a higher blood pressure target. Nevertheless, the risks associated with the two blood pressure targets being compared in the STEPCARE trial appear similar. 
Participants may not benefit from the study. If the doctor determines during the study that continuing the study treatment harms the participant, the study treatment for this patient will be stopped. Participants will then be treated according to the local guideline recommendations and receive standard care.
All participation in the trial is important as it provides the foundation of information needed to assess the optimal treatment for people who have suffered cardiac arrest, which could lead to more lives being saved and a better recovery for cardiac arrest patients. 

Does participating involve any costs?

Participation in the study is not associated with any costs for patients. 

What data will be collected and how will my personal information be kept confidential during the study?

Each participant will be assigned a unique identification number which will be used to identify them throughout the trial, ensuring the confidentiality of participants’ identities and personal information. 
By consenting to participate in the study, participants permit information from their health record to be associated with a unique study identification number. This data, including health data and medical data, will be used by the study sponsor to meet the scientific aims of the study. The medical information collected throughout the study will be transferred into the study database and assessed to allow the study results to be analyzed, reported, or published for scientific purposes. 
The study team maintains strict confidentiality of participants’ identities during and after the trial. The Research and Ethics Committee may access the collected data to monitor and ensure that the study is correctly executed. All staff are obligated to safeguard the privacy of research participants by confidentiality and are prohibited from disclosing any information that could reveal their identity.
Individual patient data will be managed under each participating country’s legislation for medical records management.

Can I opt out of the study?

A patient may decide to withdraw from the trial at any time and will then receive standard treatment. Permission to use gathered data from participants who have chosen not to continue in the study may be requested. 

Will there be any follow-up?

Participants will be invited to two follow-up visits, one at 30 days and another at 6 months following randomization. There will also be a 12-month follow-up for patients participating in the extended follow-up substudy. The follow-ups will be either by telephone, a digital meeting or a physical visit at the hospital, depending on which approach each participating site decides to perform. 

What will happen to the research study’s results, and will they be provided to me?

The trial is expected to be completed in 2026. The main research findings will be published in three separate articles following the 6-month follow-up. Participants are entitled to information about the overall study results at the end of the trial. A publication of the study with a summary of the results will be made available through a link provided on this website.
The research results from the trial may be presented at conferences or in scientific publications. The data collected about trial participants will be anonymous, making it impossible to identify individual participants after the study.