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Stepcare Extended Follow-up Substudy

RecruitingNAAges 18 Years - anyAllRegion Skane
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
All OHCA participants randomized in the STEPCARE trial at the extended follow-up participating sites, who survive and provide consent, with no further inclusion or exclusion criteria. The inclusion and exclusion criteria for the STEPCARE trial are: * 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. For caregivers, the eligibility will be that they live with, or have weekly or more frequent contact (in person or over the telephone) with the post OHCA survivor. Only one nominated caregiver per post OHCA survivor will be able to be included in the study. This would typically be the caregiver that would identify as the primary caregiver of the post OHCA survivor if needed, but may also be another close family member.
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What it tests

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

34 sites
Princess Alexandra Hospital
Brisbane, Australia
The Sutherland Hospital
Caringbah, Australia
The Prince Charles Hospital
Chermside, Australia
Nepean hospital
Kingswood, Australia
St George hospital
Kogarah, Australia
Liverpool hospital
Liverpool, Australia
Austin hospital
Melbourne, Australia
Royal North Shore Hospital
Sydney, Australia

โ€ฆand 26 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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