Pain After Cardiac Arrest and Resuscitation (PAINCARE) (PAINCARE)
11. mai 2026 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Detaljert beskrivelse
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.
Studietype
Observasjonsmessig
Registrering (Antatt)
300
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Joachim P Düring, MD, PhD
- Telefonnummer: +46705917599
- E-post: joachim.during@med.lu.se
Studer Kontakt Backup
- Navn: Mia H Hylén, RN, PhD
- Telefonnummer: +46708277226
- E-post: mia.hylen@skane.se
Studiesteder
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Halmstad, Sverige
- Rekruttering
- Dep. of Intensive Care Halmstad Lasarett
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Ta kontakt med:
- Johan Undén, MD, PhD
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Malmö, Sverige, 20205
- Rekruttering
- Department of Intensive Care, Skåne University Hospital
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Ta kontakt med:
- Joachim P Düring, MD, PhD
- Telefonnummer: +46705917599
- E-post: joachim.during@med.lu.se
-
Ta kontakt med:
- Mia H Hylén, RN, PhD
- E-post: mia.hylen@skane.se
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Hovedetterforsker:
- Joachim P Düring, MD, PhD
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Umeå, Sverige
- Rekruttering
- Dep. of Intensive Care, Norrlands Universitets Sjukhus
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Ta kontakt med:
- Matthias Schien
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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.
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
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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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Cumulative Time in Moderate or Severe Pain While Alive and in the ICU Through 168 Hours
Tidsramme: 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
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Proportion of Evaluable Alive-in-ICU Time Spent in Moderate or Severe Pain Through 168 Hours
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Moderate or Severe Pain at 6 Months
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Joachim P Düring, MD, PhD, Lunds Universitet, Institutionen för kliniska vetenskaper, Lund, Anesthesia and Intensive Care, Skåne University Hospital , Malmö, Sweden
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
15. oktober 2023
Primær fullføring (Antatt)
19. mai 2026
Studiet fullført (Antatt)
31. oktober 2028
Datoer for studieregistrering
Først innsendt
27. april 2026
Først innsendt som oppfylte QC-kriteriene
27. april 2026
Først lagt ut (Faktiske)
4. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
14. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
11. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- STEPCARE_PAINCARE
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
Upon reasonable request to Principal investigator after publication of the STEPCARE and PAINCARE studies
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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