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STEPCARE

Study Details

  • Full title of clinical trial: Sedation, Temperature and Pressure after Cardiac Arrest and Resuscitation – the STEPCARE trial

  • Study design: International, multicenter, parallel group, non-commercial, randomized, factorial, superiority trial in which sedation, temperature and blood pressure strategies will be studied.

  • Chief Investigator: Prof Niklas Nielsen (Lund University), Prof Matt Wise (UK Chief Investigator, Cardiff & Vale UHB)

  • Sponsor: Region Skane, Helsingborgs Hospital, Sweden

  • UK Lead Organisation: Cardiff & Vale University Health Board

  • REC approval: 23/WA/0342

  • IRAS: 328857

  • Study website: https://stepcare.org 

  • Status: Recruiting

Lay 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.

 

CEDAR's role

  • Development of UK-specific study documentation
  • Submission to HRA/HCRW and REC for UK-wide approvals
  • Submission of amendments 
  • Trial management support to UK Lead Site (Cardiff)