Pain After Cardiac Arrest and Resuscitation (PAINCARE)

Official title

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

Overview

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.

Detailed description

PAINCARE is an exploratory observational substudy. The available sample size is expected to be approximately 300 participants and will be determined by PAINCARE participation, consent status, availability of PAINCARE data, and eligibility for the relevant analysis population. The primary analysis will estimate cumulative time in moderate/severe pain while alive and in the ICU from randomization through 168 hours, ICU discharge, or death, whichever occurs first. Secondary analyses will evaluate associations between early pain burden and selected ICU and patient-reported outcomes. Missingness will be reported by variable, timepoint, site, and ascertainment mode where feasible. Prespecified analysis rules distinguish missing scorable intervals from non-scorable intervals, allow deterministic imputation only for isolated missing scorable intervals meeting prespecified criteria, and use endpoint-specific analysis populations for secondary and exploratory analyses. Sensitivity analyses will assess robustness to assumptions about pain-data completeness, deterministic imputation, non-scorable intervals, pain-state thresholds, and ascertainment mode. Analyses will be primarily descriptive and associational; findings outside the primary analysis will be considered hypothesis-generating. PAINCARE includes both retrospectively and prospectively ascertained participants according to local approvals and substudy implementation.

Primary outcome measures

• Cumulative Time in Moderate or Severe Pain While Alive and in the ICU Through 168 Hours [Time frame: From randomization through 168 hours, ICU discharge, or death, whichever occurs first]

Secondary outcome measures (5)

• Proportion of Evaluable Alive-in-ICU Time Spent in Moderate or Severe Pain Through 168 Hours [Time frame: From randomization through 168 hours, ICU discharge, or death, whichever occurs first]
• Delirium Burden Through 168 Hours [Time frame: From randomization through 168 hours]
• Hours Alive and Free of Invasive Ventilatory Support Through Day 30 [Time frame: From randomization through day 30]
• ICU-Free Days Alive Through Day 30 [Time frame: From randomization through day 30]
• Moderate or Severe Pain at 1 Month [Time frame: At 1 month]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Sweden · 3 centers

• Dep. of Intensive Care Halmstad Lasarett — Halmstad
• Department of Intensive Care, Skåne University Hospital — Malmö
• Dep. of Intensive Care, Norrlands Universitets Sjukhus — Umeå

Publications

• Niemela VH, Reinikainen M, Nielsen N, Bass F, Young P, Lilja G, Dankiewicz J, Hammond N, Hastbacka J, Levin H, Moseby-Knappe M, Saxena M, Tiainen M, Ceric A, Holgersson J, Kamp CB, Tirkkonen J, Oksanen T, Kaakinen T, Bendel S, During J, Lybeck A, Johnsson J, Unden J, Lundin A, Kahlin J, Grip J, Lotman E, Romundstad L, Seidel P, Stammet P, Graf T, Mengel A, Leithner C, Nee J, Druwe P, Ameloot K, Wi PMID 40392139
• Holgersson J, Niemela V, Skrifvars MB, Kamp-Jorgensen C, Saxena M, Young P, Bass F, Dankiewicz J, Hammond N, Hastbacka J, Levin H, Lilja G, Moseby-Knappe M, Tiainen M, Reinikainen M, Ceric A, During J, Lybeck A, Rodriguez-Santos D, Johnsson J, Unden J, Lundin A, Kahlin J, Grip J, Rosell J, Lotman EM, Navarra L, Crichton B, Knight D, Williams A, Romundstad L, Seidel P, Stammet P, Graf T, Mengel A, PMID 40222389
• Ceric A, Dankiewicz J, Hastbacka J, Young P, Niemela VH, Bass F, Skrifvars MB, Hammond N, Saxena M, Levin H, Lilja G, Moseby-Knappe M, Tiainen M, Reinikainen M, Holgersson J, Kamp CB, Wise MP, McGuigan PJ, White J, Sweet K, Keeble TR, Glover G, Hopkins P, Remmington C, Cole JM, Gorgoraptis N, Pogson DG, Jackson P, During J, Lybeck A, Johnsson J, Unden J, Lundin A, Kahlin J, Grip J, Lotman EM, Romu PMID 40178107

Identifiers

NCT: NCT07564778 · STEPCARE_PAINCARE

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗