Pain After Cardiac Arrest and Resuscitation (PAINCARE) (PAINCARE)
11 mai 2026 mis à jour par: Joachim Düring, Region Skane
Characterizing and Quantifying Pain After Cardiac Arrest and Resuscitation: Insights From the PAINCARE Substudy of the STEPCARE 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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Description détaillée
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.
Type d'étude
Observationnel
Inscription (Estimé)
300
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Joachim P Düring, MD, PhD
- Numéro de téléphone: +46705917599
- E-mail: joachim.during@med.lu.se
Sauvegarde des contacts de l'étude
- Nom: Mia H Hylén, RN, PhD
- Numéro de téléphone: +46708277226
- E-mail: mia.hylen@skane.se
Lieux d'étude
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Halmstad, Suède
- Recrutement
- Dep. of Intensive Care Halmstad Lasarett
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Contact:
- Johan Undén, MD, PhD
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Malmö, Suède, 20205
- Recrutement
- Department of Intensive Care, Skåne University Hospital
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Contact:
- Joachim P Düring, MD, PhD
- Numéro de téléphone: +46705917599
- E-mail: joachim.during@med.lu.se
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Contact:
- Mia H Hylén, RN, PhD
- E-mail: mia.hylen@skane.se
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Chercheur principal:
- Joachim P Düring, MD, PhD
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Umeå, Suède
- Recrutement
- Dep. of Intensive Care, Norrlands Universitets Sjukhus
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Contact:
- Matthias Schien
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
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.
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Cumulative Time in Moderate or Severe Pain While Alive and in the ICU Through 168 Hours
Délai: From randomization through 168 hours, ICU discharge, or death, whichever occurs first
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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.
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From randomization through 168 hours, ICU discharge, or death, whichever occurs first
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Proportion of Evaluable Alive-in-ICU Time Spent in Moderate or Severe Pain Through 168 Hours
Délai: From randomization through 168 hours, ICU discharge, or death, whichever occurs first
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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.
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From randomization through 168 hours, ICU discharge, or death, whichever occurs first
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Delirium Burden Through 168 Hours
Délai: From randomization through 168 hours
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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.
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From randomization through 168 hours
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Hours Alive and Free of Invasive Ventilatory Support Through Day 30
Délai: From randomization through day 30
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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.
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From randomization through day 30
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ICU-Free Days Alive Through Day 30
Délai: From randomization through day 30
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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.
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From randomization through day 30
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Moderate or Severe Pain at 1 Month
Délai: At 1 month
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Moderate or severe pain at the 1-month follow-up assessment, defined as Numeric Rating Scale score greater than 3 for worst pain on movement during the preceding 24 hours.
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At 1 month
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Moderate or Severe Pain at 6 Months
Délai: At 6 months
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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.
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At 6 months
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Health-Related Quality of Life at 6 Months
Délai: At 6 months
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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.
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At 6 months
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Mobilization During ICU Care
Délai: From randomization through 168 hours
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Mobilization during ICU care categorized as ICU Mobility Scale greater than 1 versus 1 or lower.
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From randomization through 168 hours
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Joachim P Düring, MD, PhD, Lunds Universitet, Institutionen för kliniska vetenskaper, Lund, Anesthesia and Intensive Care, Skåne University Hospital , Malmö, Sweden
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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, Wise MP, McGuigan PJ, White J, Govier M, Maccaroni M, Ostermann M, Hopkins P, Proudfoot A, Handslip R, Pogson D, Jackson P, Nichol A, Haenggi M, Hilty MP, Iten M, Schrag C, Nafi M, Joannidis M, Robba C, Pellis T, Belohlavek J, Rob D, Arabi Y, Buabbas S, Yew Woon C, Aneman A, Stewart A, Arnott C, Ramanan M, Panwar R, Delaney A, Reade M, Venkatesh B, Navarra L, Crichton B, Knight D, Williams A, Friberg H, Cronberg T, Jakobsen JC, Skrifvars MB. Higher versus lower mean arterial blood pressure after cardiac arrest and resuscitation (MAP-CARE): A protocol for a randomized clinical trial. Acta Anaesthesiol Scand. 2025 Jul;69(6):e70040. doi: 10.1111/aas.70040.
- 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, Leithner C, Nee J, Druwe P, Ameloot K, Wise M, Riddel J, Ahmed M, Buckel M, Mc Guigan P, Maharaj R, Wyncoll D, Thomas M, White J, Keeble TR, Pogson D, Nichol A, Haenggi M, Hilty MP, Iten M, Schrag C, Nafi M, Joannidis M, Robba C, Pellis T, Belohlavek J, Smid O, Rob D, Arabi Y, Buabbas S, Yew Woon C, Aneman A, Stewart A, Bernard S, Palmer-Simpson C, Simpson N, Ramanan M, Reade M, Delaney A, Venkatesh B, Tirkkonen J, Oksanen T, Kaakinen T, Bendel S, Friberg H, Cronberg T, Jakobsen J, Nielsen N. 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. Acta Anaesthesiol Scand. 2025 May;69(5):e70034. doi: 10.1111/aas.70034.
- 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, Romundstad L, Seidel P, Stammet P, Graf T, Mengel A, Leithner C, Nee J, Druwe P, Ameloot K, Nichol A, Haenggi M, Hilty MP, Iten M, Schrag C, Nafi M, Joannidis M, Robba C, Pellis T, Belohlavek J, Rob D, Arabi YM, Buabbas S, Yew Woon C, Aneman A, Stewart A, Reade M, Delcourt C, Delaney A, Ramanan M, Venkatesh B, Navarra L, Crichton B, Williams A, Knight D, Tirkkonen J, Oksanen T, Kaakinen T, Bendel S, Friberg H, Cronberg T, Jakobsen JC, Nielsen N. Continuous deep sedation versus minimal sedation after cardiac arrest and resuscitation (SED-CARE): A protocol for a randomized clinical trial. Acta Anaesthesiol Scand. 2025 May;69(5):e70022. doi: 10.1111/aas.70022.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
15 octobre 2023
Achèvement primaire (Estimé)
19 mai 2026
Achèvement de l'étude (Estimé)
31 octobre 2028
Dates d'inscription aux études
Première soumission
27 avril 2026
Première soumission répondant aux critères de contrôle qualité
27 avril 2026
Première publication (Réel)
4 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
14 mai 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
11 mai 2026
Dernière vérification
1 mai 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Manifestations neurologiques
- Maladies du système nerveux
- Maladies cardiovasculaires
- Les troubles mentaux
- Maladies cardiaques
- Confusion
- Manifestations neurocomportementales
- Troubles neurocognitifs
- Arrêt cardiaque
- Conditions pathologiques, signes et symptômes
- Signes et symptômes
- La douleur
- Délire
- Arrêt cardiaque hors hôpital
Autres numéros d'identification d'étude
- STEPCARE_PAINCARE
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime IPD
Upon reasonable request to Principal investigator after publication of the STEPCARE and PAINCARE studies
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .