Stepcare Extended Follow-up Substudy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRegion Skane

About this trial

To provide detailed information on long-term outcomes in relation to potential neuroprotection and improvements in recovery for different targets of sedation, temperature, and pressure management in post out of hospital cardiac arrest survivors at 6 and 12 months. In addition, the impact of caring for a post OHCA survivor will be explored.

Eligibility criteria

Qualifiers

None

Disqualifiers

Inclusion criteria: out-of-hospital cardiac arrest of non-traumatic origin, minimum of 20 minutes without chest compressions (defined as stable return of spontaneous circulation. ROSC), unconsciousness (defined as not being able to obey verbal commands equal to a FOUR-score motor response of <4, or being intubated and sedated because of agitation after sustained ROSC, eligible for intensive care without restrictions or limitation, inclusion within 4 hours (240 minutes) of ROSC (or 220 minutes of stable ROSC).

Exclusion criteria: on ECMO prior to randomization, pregnancy, suspected or confirmed intracranial hemorrhage, previously randomized in the STEPCARE trial.

Trial design

Treatments tested in this trial

  • Feed back controlled temperature device
  • High MAP
  • Deep sedation
  • Fever control without a device
  • Low MAP
  • Minimal sedation

Treatment groups

600 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Sponsors and collaborators

Region Skane

Lead sponsor

Lund University

Collaborator

The George Institute for Global Health, Australia

Collaborator

Copenhagen Trial Unit, Center for Clinical Intervention Research

Collaborator

Helsinki University Central Hospital

Collaborator