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Characterizing and Quantifying Pain After Cardiac Arrest and Resuscitation: Insights From the PAINCARE Substudy of the STEPCARE Trial

Status: Recruiting
Location: See all (3) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Sweden
Dep. of Intensive Care Halmstad Lasarett
RECRUITING
Halmstad
Department of Intensive Care, Skåne University Hospital
RECRUITING
Malmö
Dep. of Intensive Care, Norrlands Universitets Sjukhus
RECRUITING
Umeå
Contact Information
Primary
Joachim P Düring, MD, PhD
joachim.during@med.lu.se
+46705917599
Backup
Mia H Hylén, RN, PhD
mia.hylen@skane.se
+46708277226
Time Frame
Start Date: 2023-10-15
Estimated Completion Date: 2028-10-31
Participants
Target number of participants: 300
Treatments
Comatose out-of-hospital cardiac arrest patients
Adult participants in the STEPCARE trial (NCT05564754) enrolled at PAINCARE-participating sites under approved PAINCARE substudy procedures and not withdrawn from use of study data according to parent-trial procedures. PAINCARE inclusion may occur retrospectively or prospectively according to local approvals and substudy implementation.
Related Therapeutic Areas
Sponsors
Leads: Region Skane

This content was sourced from clinicaltrials.gov