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임상시험 NCT07290712 (PICS-DACH)은(는) 소아 중환자 증후군, PICS-F에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
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빈 의과대학교Post-Intensive Care Syndrome - Multicentre Prospective Registry Database of the DACH Region (PICS-DACH) 5,000
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT07290712 (PICS-DACH)은(는) 소아 중환자 증후군, PICS-F에 대해 알아보는 관찰연구입니다. 현재 상태는 모집중이며, 연구는 2026년 2월 4일에 시작되어 5,000명의 참여자를 모집하고 있습니다. 빈 의과대학교이(가) 진행하며, 2035년 11월 1일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2026년 2월 19일에 갱신되었습니다.
간단한 개요
Post-Intensive Care Syndrome (PICS) refers to long-term cognitive, physical, and psychological impairments that can arise after intensive care treatment. These symptoms may begin within 24 hours of ICU admission and persist for years. Affected patients and their families (PICS-F) face significant burdens, with up to 94% of relatives impacted. Given its high prevalence and socioeconomic impact, this prospective regist...더 보기
상세한 설명
BACKGROUND Post-Intensive Care Syndrome (PICS) refers to newly occurring or intensified cognitive, physical, and psychological long-term effects, as well as pain and socioeconomic effects resulting from intensive care treatment. Symptoms can appear as early as 24 hours after admission to the intensive care unit (ICU) and persist for 5-15 years after discharge. The rate of affected individuals is very high. Three mont...더 보기
공식 제목
Post-Intensive Care Syndrome - Multicentre Prospective Registry Database of the DACH Region
질환명
소아 중환자 증후군PICS-F출판물
이 임상시험에 대해 발표된 과학 논문 및 연구 자료.기타 연구 식별자
- PICS-DACH
NCT 번호
실제 연구 시작일
2026-02-04
최신 업데이트 게시
2026-02-19
예상 연구 완료일
2035-11-01
계획된 등록 인원
5,000
연구종류
관찰연구
상태
모집중
키워드
PICS
PICS-F
ICU
Intensive Care Unit
Critical Care
Critical Illness
Post Intensive Care Syndrome
Post Intensive Care Syndrome Family
PICS-F
ICU
Intensive Care Unit
Critical Care
Critical Illness
Post Intensive Care Syndrome
Post Intensive Care Syndrome Family
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Diagnosis of Post-Intensive Care Syndrome (PICS) | Frequency of PICS diagnosis defined as the presence of at least one new or worsened impairment in one of the PICS domains (number/percentage) | up to 5 years |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Frequency of PICS sub-domains | Frequency of diagnosis of PICS-subdomains | up to 5 years |
Frailty status | Frailty status assessed by the Clinical Frailty Scale (CFS; score 1-9, higher scores indicate worse frailty). | up to 5 years |
Post-Intensive Care Syndrome symptoms assessed by the PICS Questionnaire (PICSq) | PICS symptoms assessed by the PICSq (validated questionnaire 0-45 points; higher scores indicate greater impairment). | up to 5 years |
Physical function assessed by the Barthel Index | Change in activities of daily living, assessed by the Barthel Index (score 0-100; higher scores indicate better function). | up to 5 years |
Physical function assessed by the Timed Up-and-Go Test | Change in mobility, assessed by the Timed Up-and-Go(time in seconds; longer times indicate worse performance). | up to 5 years |
Physical function assessed by Handgrip Strength | Muscle strength, assessed by handgrip dynamometry (maximum grip strength in kg; higher values indicate better function). | up to 5 years |
Physical function assessed by the 6-Minute Walk Test (6MWT) | 6MWT (distance walked in meters; higher values indicate better function). | up to 5 years |
Physical function assessed by the 2-Minute Walk Test (2MWT) | ´2MWT (distance walked in meters; higher values indicate better function). | up to 5 years |
Physical function assessed by the SPPB | Physical function, assessed by the Short Physical Performance Battery (SPPB, score 0-12; higher scores indicate better performance). | up to 5 years |
Nutritional status assessed by the MNA | Nutritional status, assessed by the Mini Nutritional Assessment (MNA, score 0-30; higher scores indicate better nutritional status). | up to 5 years |
Health-related quality of life assessed by EQ-5D-5L | Health-related quality of life, assessed by the EQ-5D-5L (index score; higher values indicate better quality of life). | up to 5 years |
Disability assessed by the WHO Disability Assessment Schedule (WHODAS 2.0) | Disability, assessed by the WHODAS 2.0, with higher scores indicating greater disability. | up to 5 years |
Cognitive function assessed by the MiniCog | Cognitive function, assessed by the MiniCog (score 0-5; higher scores indicate better cognition). | up to 5 years |
Cognitive function assessed by the Animal Naming Test | Verbal fluency, assessed by the Animal Naming Test (number of animals named in 60 seconds; higher values indicate better cognition). | up to 5 years |
Cognitive function assessed by the RBANS | Cognition, assessed by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS; higher scores indicate better cognition). | up to 5 years |
Cognitive function assessed by the TMT | Executive function, assessed by the Trail Making Test (TMT A and B, completion time in seconds; longer times indicate worse performance). | up to 5 years |
Depression assessed by the PHQ | Depression severity, assessed by the Patient Health Questionnaire (PHQ, higher scores indicate worse depression). | up to 5 years |
Anxiety assessed by the GAD | Anxiety severity, assessed by the Generalized Anxiety Disorder scale (GAD, higher scores indicate worse anxiety). | up to 5 years |
PTSD symptoms assessed by the IES-R | Post-traumatic stress disorder (PTSD) symptoms, assessed by the Impact of Event Scale - Revised (IES-R; higher scores indicate worse PTSD symptoms). | up to 5 years |
Pain assessed by the McGill Pain Questionnaire | Pain severity, assessed by the McGill Pain Questionnaire (higher scores indicate worse pain). | up to 5 years |
Frequency of dysphagia | Frequency of clinically diagnosed swallowing disorder (number / percentage) | up to 5 years |
Work ability and disability days | Change in employment status and number of disability days from baseline to 5 years, assessed by self-report (more disability days indicate worse outcome). | 5 years |
Psychiatric or psychotherapeutic care utilization | Use of psychiatric or psychotherapeutic services (yes/no), assessed from baseline to 5 years. | 5 years |
Noise annoyance assessed by the 11-point numeric noise-annoyance scale | Change in noise annoyance from baseline to 5 years, assessed by the 11-point numeric scale (0-10; higher scores indicate higher annoyance). | 5 years |
Noise annoyance assessed by the 5-point verbal scale | Change in noise annoyance from baseline to 5 years, assessed by the 5-point verbal scale (1-5; higher scores indicate higher annoyance). | 5 years |
Noise sensitivity assessed by the LEF-K questionnaire | Change in noise sensitivity from baseline to 5 years, assessed by the LEF-K (higher scores indicate greater sensitivity). | 5 years |
ICU environmental exposure measured by HIAwear/Sensorbox | Change in ICU environmental exposure from baseline to 5 years, measured continuously with HIAwear/Sensorbox (parameters include noise, light, particulate matter, temperature, humidity; higher values indicate greater exposure). | 5 years |
Atmospheric environmental exposure (ozone, nitrogen oxides, carbon monoxide, particulate matter) | Change in atmospheric exposure from baseline to 5 years, assessed by pollutant concentrations (O3, NO, NO2, NOx, CO, PM1, PM2.5, PM10; higher values indicate greater exposure). | 5 years |
Anxiety and depression in relatives assessed by the HADS | Change in anxiety and depression symptoms of relatives from baseline to 5 years, assessed by the HADS (score 0-21; higher scores indicate worse symptoms). | 5 years |
Post-traumatic stress in relatives assessed by the IES-R | Change in PTSD symptoms of relatives from baseline to 5 years, assessed by the IES-R (higher scores indicate worse PTSD symptoms). | 5 years |
Work ability of relatives | Change in work status and disability days of relatives from baseline to 5 years, assessed by self-report (more disability days indicate worse outcome). | 5 years |
Psychiatric or psychotherapeutic care utilization by relatives | Use of psychiatric or psychotherapeutic services (yes/no), assessed in relatives from baseline to 5 years. | 5 years |
Body resistance (R) | Body resistance (R) measured by BIA (Body impedance analysis) | up to 5 years |
Body reactance (Xc) | Body reactance (Xc) measured by BIA (Body impedance analysis) | up to 5 years |
참여 도우미
적격성 기준
연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체
- Patients with an ICU stay longer than 72 hours will be included
- Age < 18 years old
- Patients who receive end-of-life care at the time of screening
빈 의과대학교216개의 진행 중인 임상시험 탐색 가능연구 책임자
Stefan Schaller, 책임연구자, Professor of Anaesthesia and Anaesthesiological Intensive Care Medicine, Medical University of Vienna
연구 대표 연락처
연락처: PICS-DACH Steering Committee, +4314040041020, [email protected]
연락처: Study Coordination AAI MUV, [email protected]
4 2개국에 임상시험 장소
Vienna
Medical University of Vienna, Vienna, Vienna, 1090, Austria
Stefan J Schaller, MD, 연락처, +4314040041020, [email protected]
Marion Wiegele, MD, 연락처
모집중
Bavaria
Universitätsklinikum Augsburg, Augsburg, Bavaria, 86156, Germany
Philipp Simon, MD, 연락처, [email protected]
Manfred Weiss, MD, 연락처, [email protected]
대상자모집전
Universitätsklinikum Würzburg, Würzburg, Bavaria, 97080, Germany
Patrick Meybohm, MD, 연락처, [email protected]
Christian Stoppe, MD, 연락처, [email protected]
대상자모집전
State of Berlin
Charité - Universitätsmedizin Berlin, Berlin, State of Berlin, 13353, Germany
Claudia Spies, MD, 연락처, +49 30 450 531 012, [email protected]
Claudia Denke, Dr., 연락처, claudia. denke@ charite. de
Bjoern Weiß, MD, 책임연구자
대상자모집전