Pain After Cardiac Arrest and Resuscitation (PAINCARE)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRegion Skane
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Restrictions or limitations of care
On extracorporeal membrane oxygenation before randomization
Pregnancy
Previously randomized in the STEPCARE trial
Trial population
STEPCARE participants at PAINCARE-participating sites who are included under approved PAINCARE substudy procedures and have not withdrawn consent for use of study data according to parent-trial procedures. PAINCARE participants may be included retrospectively or prospectively according to local approvals and substudy implementation.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
300 Participants
are grouped into 1 trial groupGroup A: Comatose out-of-hospital cardiac arrest patients
Trial outcomes
Primary outcomes
1
Cumulative Time in Moderate or Severe Pain While Alive and in the ICU Through 168 Hours
Cumulative time, in hours, spent in moderate or severe pain while alive and in the ICU from randomization through 168 hours, ICU discharge, or death, whichever occurs first. Moderate or severe pain is defined as NRS \>3, CPOT \>2, or BPS \>5. Each scheduled assessment represents the worst pain intensity since the previous assessment and is assigned to the corresponding preceding interval.
Time frame
From randomization through 168 hours, ICU discharge, or death, whichever occurs firstSecondary outcomes
1
Proportion of Evaluable Alive-in-ICU Time Spent in Moderate or Severe Pain Through 168 Hours
Proportion of evaluable alive-in-ICU time spent in moderate or severe pain during the primary 0- to 168-hour pain-burden window. The proportion is calculated as cumulative evaluable time in moderate or severe pain divided by total evaluable alive-in-ICU time, excluding time after ICU discharge or death and excluding non-scorable and remaining missing scorable intervals.
Time frame
From randomization through 168 hours, ICU discharge, or death, whichever occurs first2
Delirium Burden Through 168 Hours
Proportion of evaluable point-prevalence delirium assessments with delirium present among assessments recorded as delirium present or absent through 168 hours. Delirium is assessed using the Confusion Assessment Method for the ICU or the Intensive Care Delirium Screening Checklist. Assessments recorded as not assessable are reported separately and do not contribute to the denominator; assessments recorded as not done are reported as missing.
Time frame
From randomization through 168 hours3
Hours Alive and Free of Invasive Ventilatory Support Through Day 30
Number of hours from randomization to day 30 during which the participant is alive and not receiving invasive ventilatory support. Participants who die before day 30 are assigned zero hours alive and free of invasive ventilatory support.
Time frame
From randomization through day 304
ICU-Free Days Alive Through Day 30
Number of days from randomization to day 30 during which the participant is alive and discharged from the ICU. Participants who die before day 30 are assigned zero ICU-free days.
Time frame
From randomization through day 30Other outcomes
1
Moderate or Severe Pain at 6 Months
Moderate or severe pain at the 6-month follow-up assessment, defined as Numeric Rating Scale score greater than 3 for worst pain on movement during the preceding 24 hours.
Time frame
At 6 months2
Health-Related Quality of Life at 6 Months
Health-related quality of life at 6 months assessed using EQ-5D-5L. For exploratory binary analyses, clinically relevant health-related quality-of-life problems are defined as at least one EQ-5D-5L dimension scored at level 3 or higher. EQ-5D-5L dimension profiles and EQ VAS will also be summarized descriptively.
Time frame
At 6 months3
Mobilization During ICU Care
Mobilization during ICU care categorized as ICU Mobility Scale greater than 1 versus 1 or lower.
Time frame
From randomization through 168 hoursSponsors and contacts
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Source ClinicalTrials.gov