Higher versus lower mean arterial blood pressure after cardiac arrest and resuscitation (MAP-CARE): A protocol for a randomized clinical trial.
V H Niemelä, M Reinikainen, N Nielsen...
https://pubmed.ncbi.nlm.nih.gov/40392139/Actively Recruiting
Led by Region Skane · Updated on 2026-05-14
300
Participants Needed
3
Research Sites
128 weeks
Total Duration
Researchers are investigating pain levels in adults who have experienced out-of-hospital cardiac arrest and are receiving intensive care. This observational substudy, PAINCARE, is part of the larger international STEPCARE trial that looks at sedation, temperature, and blood pressure strategies after cardiac arrest. The study aims to understand how much pain patients experience early in intensive care and how this pain relates to outcomes like delirium, ventilator-free days, and long-term pain reports. The study collects detailed pain assessments during the first 168 hours after patients are randomized, using validated self-report or behavioral pain tools. Participants are adults who have had cardiac arrest outside the hospital, have returned spontaneous circulation, and are comatose upon enrollment. The substudy includes both retrospective and prospective participants depending on local approvals. Analyses will focus on the time patients spend in moderate to severe pain while in the ICU, as well as associations between early pain and various health outcomes. Participants pain levels will be closely monitored along with other health factors like delirium and ventilator use during their ICU stay. Researchers will also assess pain one month after the cardiac arrest. Data completeness and quality will be carefully reported and analyzed. The study does not test treatments but observes pain and outcomes to generate hypotheses for future research. Participation duration varies but involves monitoring through ICU stay and follow-up at one month.
CONDITIONS
Pain After Cardiac Arrest and Resuscitation (PAINCARE)
J
Joachim P Düring, MD, PhD
M
Mia H Hylén, RN, PhD
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Region Skane
Lead Sponsor
You may qualify if you...
You will not qualify if you...
Duration - Within 4 hours after return of spontaneous circulation
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Up to 168 hours or until ICU discharge or death
Participants are observed for pain intensity and other health outcomes while alive and in the ICU up to 168 hours, ICU discharge, or death, whichever occurs first.
Continuous monitoring in the ICU
Duration - 1 month
Participants are followed up to assess pain and other outcomes at 1 month after cardiac arrest.
1 follow-up visit at 1 month
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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https://pubmed.ncbi.nlm.nih.gov/40392139/Johan Holgersson, V Niemelä, M B Skrifvars...
https://pubmed.ncbi.nlm.nih.gov/40222389/A Ceric, J Dankiewicz, J Hästbacka...
https://pubmed.ncbi.nlm.nih.gov/40178107/Region Skane
Lead Sponsor