NCT07564778 Pain After Cardiac Arrest and Resuscitation (PAINCARE)
| NCT ID | NCT07564778 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Region Skane |
| Condition | Pain |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2023-10-15 |
| Primary Completion | 2026-05-19 |
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 300 participants in total. It began in 2023-10-15 with a primary completion date of 2026-05-19.
⚠ 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
The PAINCARE substudy is an observational cohort substudy nested within the international STEPCARE trial, which evaluates sedation, temperature, and mean arterial pressure strategies after out-of-hospital cardiac arrest. PAINCARE aims to describe the burden of pain during early intensive care after cardiac arrest and to evaluate associations between early pain burden and selected ICU and patient-reported outcomes. Pain is common in critically ill patients but may be difficult to assess in patients who are unconscious, sedated, mechanically ventilated, or unable to self-report. PAINCARE collects structured pain assessments during the first 168 hours after randomization using validated self-report or behavioral pain instruments and relates early pain burden to outcomes including delirium burden, ventilator-free time, ICU-free time, and follow-up pain outcomes. All analyses are observational; PAINCARE is not designed to determine whether modifying pain burden improves outcomes.
Eligibility Criteria
Inclusion Criteria: * Out-of-hospital cardiac arrest * Adult, age 18 years or older * Spontaneous circulation without chest compressions for at least 20 minutes * Comatose, defined as not obeying verbal commands * Enrolled within 4 hours after return of spontaneous circulation Exclusion Criteria: * Restrictions or limitations of care * On extracorporeal membrane oxygenation before randomization * Pregnancy * Previously randomized in the STEPCARE trial * Trauma or hemorrhage as the presumed cause of arrest * Suspected or confirmed intracranial hemorrhage
Contact & Investigator
Joachim P Düring, MD, PhD
PRINCIPAL INVESTIGATOR
Lunds Universitet, Institutionen för kliniska vetenskaper, Lund, Anesthesia and Intensive Care, Skåne University Hospital , Malmö, Sweden
Frequently Asked Questions
Who can join the NCT07564778 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07564778 currently recruiting?
Yes, NCT07564778 is actively recruiting participants. Contact the research team at joachim.during@med.lu.se for enrollment information.
Where is the NCT07564778 trial being conducted?
This trial is being conducted at Halmstad, Sweden, Malmö, Sweden, Umeå, Sweden.
Who is sponsoring the NCT07564778 clinical trial?
NCT07564778 is sponsored by Region Skane. The principal investigator is Joachim P Düring, MD, PhD at Lunds Universitet, Institutionen för kliniska vetenskaper, Lund, Anesthesia and Intensive Care, Skåne University Hospital , Malmö, Sweden. The trial plans to enroll 300 participants.