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Universidade de Medicina de VienaPost-Intensive Care Syndrome - Multicentre Prospective Registry Database of the DACH Region (PICS-DACH) 5.000
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT07290712 (PICS-DACH) é um estudo observacional para SICP, PICS-F. Seu status atual é: em recrutamento. O estudo começou em 4 de fevereiro de 2026 e pretende incluir 5.000 participantes. Coordenado por a Universidade de Medicina de Viena e deve ser concluído em 1 de novembro de 2035. Essas informações foram atualizadas no ClinicalTrials.gov em 19 de fevereiro de 2026.
Resumo
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...Mostrar mais
Descrição detalhada
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...Mostrar mais
Título oficial
Post-Intensive Care Syndrome - Multicentre Prospective Registry Database of the DACH Region
Condições médicas
SICPPICS-FPublicações
Artigos científicos e trabalhos de pesquisa publicados sobre este estudo clínico:Outros IDs do estudo
- PICS-DACH
Número NCT
Data de início (real)
2026-02-04
Última atualização postada
2026-02-19
Data de conclusão (estimada)
2035-11-01
Inscrição (estimada)
5.000
Tipo de estudo
Observacional
Status
Em recrutamento
Palavras-chave
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
Desfecho primário
Desfecho secundário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
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 |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
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 |
Assistente de participação
Critérios de elegibilidade
Idades elegíveis
Adulto, Idoso
Idade mínima
18 Years
Sexos elegíveis
Todos
- 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
Universidade de Medicina de Viena216 estudos clínicos ativos para explorarResponsável pelo estudo
Stefan Schaller, Investigador principal, Professor of Anaesthesia and Anaesthesiological Intensive Care Medicine, Medical University of Vienna
Contato central do estudo
Contato: PICS-DACH Steering Committee, +4314040041020, [email protected]
Contato: Study Coordination AAI MUV, [email protected]
4 Locais do estudo em 2 países
Vienna
Medical University of Vienna, Vienna, Vienna, 1090, Austria
Stefan J Schaller, MD, Contato, +4314040041020, [email protected]
Marion Wiegele, MD, Contato
Em recrutamento
Bavaria
Universitätsklinikum Augsburg, Augsburg, Bavaria, 86156, Germany
Philipp Simon, MD, Contato, [email protected]
Manfred Weiss, MD, Contato, [email protected]
Ainda não recrutando
Universitätsklinikum Würzburg, Würzburg, Bavaria, 97080, Germany
Patrick Meybohm, MD, Contato, [email protected]
Christian Stoppe, MD, Contato, [email protected]
Ainda não recrutando
State of Berlin
Charité - Universitätsmedizin Berlin, Berlin, State of Berlin, 13353, Germany
Claudia Spies, MD, Contato, +49 30 450 531 012, [email protected]
Claudia Denke, Dr., Contato, claudia. denke@ charite. de
Bjoern Weiß, MD, Investigador principal
Ainda não recrutando