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De klinische studie NCT07290712 (PICS-DACH) voor PICS, PICS-F is rekruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag. | ||
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Medische Universiteit van WenenPost-Intensive Care Syndrome - Multicentre Prospective Registry Database of the DACH Region (PICS-DACH) 5.000
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De klinische studie NCT07290712 (PICS-DACH) is een observationeel studie bij PICS, PICS-F met de status rekruterend. Het doel is om 5.000 deelnemers te includeren vanaf 4 februari 2026. De studie wordt geleid door Medische Universiteit van Wenen en de voltooiing is gepland op 1 november 2035. Laatste update op ClinicalTrials.gov: 19 februari 2026.
Beknopte samenvatting
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...Toon meer
Uitgebreide beschrijving
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...Toon meer
Officiële titel
Post-Intensive Care Syndrome - Multicentre Prospective Registry Database of the DACH Region
Aandoeningen
PICSPICS-FPublicaties
Wetenschappelijke artikelen en onderzoekspapers gepubliceerd over deze klinische studie:Andere studie-ID's
- PICS-DACH
NCT-ID
Startdatum (Werkelijk)
2026-02-04
Laatste update geplaatst
2026-02-19
Verwachte einddatum
2035-11-01
Inschrijving (Geschat)
5.000
Studietype
Observationeel
Status
Rekruterend
Trefwoorden
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
Primaire uitkomst
Secundaire uitkomst
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
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 |
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
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 |
Deelname-assistent
Geschiktheidscriteria
Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
18 Years
Geslachten die in aanmerking komen voor de studie
Allen
- 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
Medische Universiteit van Wenen216 actieve klinische studies om te verkennenVerantwoordelijke instantie
Stefan Schaller, Hoofdonderzoeker, Professor of Anaesthesia and Anaesthesiological Intensive Care Medicine, Medical University of Vienna
Centraal Contactpersoon
Contact: PICS-DACH Steering Committee, +4314040041020, [email protected]
Contact: Study Coordination AAI MUV, [email protected]
4 Studielocaties in 2 landen
Vienna
Medical University of Vienna, Vienna, Vienna, 1090, Austria
Stefan J Schaller, MD, Contact, +4314040041020, [email protected]
Marion Wiegele, MD, Contact
Rekruterend
Bavaria
Universitätsklinikum Augsburg, Augsburg, Bavaria, 86156, Germany
Philipp Simon, MD, Contact, [email protected]
Manfred Weiss, MD, Contact, [email protected]
Nog niet rekruterend
Universitätsklinikum Würzburg, Würzburg, Bavaria, 97080, Germany
Patrick Meybohm, MD, Contact, [email protected]
Christian Stoppe, MD, Contact, [email protected]
Nog niet rekruterend
State of Berlin
Charité - Universitätsmedizin Berlin, Berlin, State of Berlin, 13353, Germany
Claudia Spies, MD, Contact, +49 30 450 531 012, [email protected]
Claudia Denke, Dr., Contact, claudia. denke@ charite. de
Bjoern Weiß, MD, Hoofdonderzoeker
Nog niet rekruterend