Actively Recruiting

Age: 18Years +
All Genders
ID07564778

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

Led by Region Skane · Updated on 2026-05-14

300

Participants Needed

3

Research Sites

128 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Brief Title

Pain After Cardiac Arrest and Resuscitation (PAINCARE)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

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)

Monitoring

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

Long-term Monitoring

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

Trial Site Locations

Total: 3 locations

1

Dep. of Intensive Care Halmstad Lasarett

Halmstad, Sweden

Actively Recruiting

2

Department of Intensive Care, Skåne University Hospital

Malmö, Sweden, 20205

Actively Recruiting

3

Dep. of Intensive Care, Norrlands Universitets Sjukhus

Umeå, Sweden

Actively Recruiting

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Research Team

J

Joachim P Düring, MD, PhD

M

Mia H Hylén, RN, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

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

Fever management with or without a temperature control device after out-of-hospital cardiac arrest and resuscitation (TEMP-CARE): A study protocol for a randomized clinical trial.

Johan Holgersson, V Niemelä, M B Skrifvars...

https://pubmed.ncbi.nlm.nih.gov/40222389

Continuous deep sedation versus minimal sedation after cardiac arrest and resuscitation (SED-CARE): A protocol for a randomized clinical trial.

A Ceric, J Dankiewicz, J Hästbacka...

https://pubmed.ncbi.nlm.nih.gov/40178107