Pain After Cardiac Arrest and Resuscitation (PAINCARE) (PAINCARE)
2026년 5월 11일 업데이트: 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.
연구 개요
상태
모병
정황
상세 설명
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.
연구 유형
관찰
등록 (추정된)
300
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Joachim P Düring, MD, PhD
- 전화번호: +46705917599
- 이메일: joachim.during@med.lu.se
연구 연락처 백업
- 이름: Mia H Hylén, RN, PhD
- 전화번호: +46708277226
- 이메일: mia.hylen@skane.se
연구 장소
-
-
-
Halmstad, 스웨덴
- 모병
- Dep. of Intensive Care Halmstad Lasarett
-
연락하다:
- Johan Undén, MD, PhD
-
Malmö, 스웨덴, 20205
- 모병
- Department of Intensive Care, Skåne University Hospital
-
연락하다:
- Joachim P Düring, MD, PhD
- 전화번호: +46705917599
- 이메일: joachim.during@med.lu.se
-
연락하다:
- Mia H Hylén, RN, PhD
- 이메일: mia.hylen@skane.se
-
수석 연구원:
- Joachim P Düring, MD, PhD
-
Umeå, 스웨덴
- 모병
- Dep. of Intensive Care, Norrlands Universitets Sjukhus
-
연락하다:
- Matthias Schien
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
샘플링 방법
비확률 샘플
연구 인구
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.
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
|---|
|
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Cumulative Time in Moderate or Severe Pain While Alive and in the ICU Through 168 Hours
기간: From randomization through 168 hours, ICU discharge, or death, whichever occurs first
|
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.
|
From randomization through 168 hours, ICU discharge, or death, whichever occurs first
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Proportion of Evaluable Alive-in-ICU Time Spent in Moderate or Severe Pain Through 168 Hours
기간: From randomization through 168 hours, ICU discharge, or death, whichever occurs first
|
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.
|
From randomization through 168 hours, ICU discharge, or death, whichever occurs first
|
|
Delirium Burden Through 168 Hours
기간: From randomization 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.
|
From randomization through 168 hours
|
|
Hours Alive and Free of Invasive Ventilatory Support Through Day 30
기간: From randomization 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.
|
From randomization through day 30
|
|
ICU-Free Days Alive Through Day 30
기간: From randomization 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.
|
From randomization through day 30
|
|
Moderate or Severe Pain at 1 Month
기간: At 1 month
|
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.
|
At 1 month
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Moderate or Severe Pain at 6 Months
기간: 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.
|
At 6 months
|
|
Health-Related Quality of Life at 6 Months
기간: 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.
|
At 6 months
|
|
Mobilization During ICU Care
기간: From randomization through 168 hours
|
Mobilization during ICU care categorized as ICU Mobility Scale greater than 1 versus 1 or lower.
|
From randomization through 168 hours
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 수석 연구원: Joachim P Düring, MD, PhD, Lunds Universitet, Institutionen för kliniska vetenskaper, Lund, Anesthesia and Intensive Care, Skåne University Hospital , Malmö, Sweden
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2023년 10월 15일
기본 완료 (추정된)
2026년 5월 19일
연구 완료 (추정된)
2028년 10월 31일
연구 등록 날짜
최초 제출
2026년 4월 27일
QC 기준을 충족하는 최초 제출
2026년 4월 27일
처음 게시됨 (실제)
2026년 5월 4일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 14일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 11일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- STEPCARE_PAINCARE
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
Upon reasonable request to Principal investigator after publication of the STEPCARE and PAINCARE studies
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
통증에 대한 임상 시험
-
Bingol UniversityAtaturk University아직 모집하지 않음수술 전 불안 | 두려움 | PAIN
-
Weill Medical College of Cornell UniversityNew York University; National Center for Complementary and Integrative Health (NCCIH)모병
-
Istanbul University모병Masticatory Muscle Pain | 근시 통증 증후군 (MP)칠면조
-
Istanbul University모병이갈이 | 근막 통증 증후군 | Masticatory Muscle Pain | 현지 근육통터키 (Türkiye)