STEPCARE
Research type
Research Study
Full title
Sedation, Temperature and Pressure after Cardiac Arrest and Resuscitation: A Factorial Randomised Trial with Three Interventions
IRAS ID
328857
Contact name
Matthew Wise
Contact email
Sponsor organisation
Helsingborg Hospital, Region Skåne. Organization number 232100-0255
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 11 months, 31 days
Research summary
Cardiac arrests (where a person’s heart stops beating) outside of hospital affect around 300,000 people each year in Europe. Only 30-55% of those admitted to an intensive care unit (ICU), will survive and many will be left with a disability. Patients who are in ICU after a cardiac arrest will have many of the normal functions of their body managed by doctors using a range of medications, devices, and other treatments. Doctors aim to keep patients’ measurements within a certain range. However, we don’t know exactly what these measurements should be.
This trial aims to test how best to control three important measurements in ICU to work out which is best for patients. These are:
1. How deeply the participant is kept asleep (sedated)
2. How warm or cold they should be
3. What their blood pressure should be
The study is a randomised controlled trial which will take place in ICU departments in the UK and worldwide. It will be open to unconscious ICU adult patients who have had an out-of-hospital cardiac arrest and their heart has started pumping again. Eligible patients will be recruited into the study when they reach hospital and allocated at random to receive care which will test a combination of the 3 factors being studies (level of sedation, temperature management, and blood pressure). The team caring for the patient will know which group the participant has been allocated to, but the participant, their family, and other staff involved in the trial will not.
We will measure whether participants are alive, and if so, their health, function, and quality of life. We will collect data during participants’ time in hospital, and at 30 days and 6 months after entering the study.REC name
Wales REC 4
REC reference
23/WA/0342
Date of REC Opinion
3 Jan 2024
REC opinion
Further Information Favourable Opinion