| NCT ID | NCT05706194 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Lund University |
| Condition | Cardiac Arrest |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2023-10-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2023-10-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a prospective observational substudy of the STEPCARE trial ClinicalTrials.gov Identifier: NCT05564754) with the aim to examine whether prognostication of neurological outcome after cardiac arrest can be performed earlier than the 72 h time-point recommended by guidelines today.
Eligibility Criteria
Inclusion Criteria: Adult cardiac arrest patients with an out-of-hospital cardiac arrest of non-traumatic cause treated at hospitals recruiting patients to the STEPCARE neuroprognostication substudy. Other inclusion criteria include: * a minimum of 20 minutes without chest compressions * Unconsciousness defined as not being able to obey verbal commands (FOUR-score motor response of \<4) or being intubated and sedated because of agitation after sustained ROSC * Eligible for intensive care without restrictions or limitations * Inclusion within 4 hours of ROSC Exclusion Criteria: * On ECMO prior to randomisation * Pregnancy * Suspected or confirmed intracranial hemorrhage * Previously randomised in the STEPCARE trial * Patients with limitations in level-of-care due to for example generalized malignancy
Contact & Investigator
Niklas Nielsen, MD, PhD
STUDY CHAIR
Lund University
Frequently Asked Questions
Who can join the NCT05706194 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Cardiac Arrest. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05706194 currently recruiting?
Yes, NCT05706194 is actively recruiting participants. Contact the research team at marion.moseby_knappe@med.lu.se for enrollment information.
Where is the NCT05706194 trial being conducted?
This trial is being conducted at Helsinki, Finland, Berlin, Germany, Helsingborg, Sweden, Lund, Sweden.
Who is sponsoring the NCT05706194 clinical trial?
NCT05706194 is sponsored by Lund University. The principal investigator is Niklas Nielsen, MD, PhD at Lund University. The trial plans to enroll 1,000 participants.