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Multidimensional Dysfunction in Patients With Post-Intensive Care Syndrome in China

9 de junio de 2026 actualizado por: Hongying Jiang, MD

Multidimensional Dysfunction in Patients With Post-Intensive Care Syndrome in China: A Multi-center Real-world Study

Over the past two decades, the rapid advancement of critical care medicine has significantly reduced short-term mortality among critically ill patients. However, a growing number of intensive care unit (ICU) survivors experience persistent physical, cognitive, and psychological impairments after hospital discharge, a syndrome termed post-intensive care syndrome (PICS). Although PICS has gained increasing attention in recent years, existing studies still have multiple limitations. Given the continuously increasing number of ICU survivors in China and the marked heterogeneity in critical care delivery models across different regions and healthcare institutions, there is an urgent need for large-scale multicenter observational studies to systematically characterize the epidemiological features, multidimensional functional impairment profiles, and clinical impact of PICS in Chinese patients, thereby providing an evidence-based foundation for the development of a scientific post-ICU continuum of care.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

This multi-center observational study aims to characterize the epidemiological profile and multidimensional functional impairments of Post-Intensive Care Syndrome (PICS) in ICU survivors across China. The study will enroll approximately 800 eligible participants from four participating high-dependency units (HDUs) between January 2018 and January 2026. Data on physical, cognitive, and psychological function will be collected using validated assessment tools including the MRC score, ICU Mobility Scale, CPAx, MMSE, S5Q, PHQ-9, GAD-7, PSQI, Barthel Index, and EQ-5D-5L. The primary outcomes include the incidence of PICS and comorbidity patterns across multiple functional domains. The secondary outcomes encompass functional status, quality of life, and risk factors for PICS.

Tipo de estudio

De observación

Inscripción (Estimado)

800

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

  • Nombre: Hongying Jiang, MD
  • Número de teléfono: +861056981098
  • Correo electrónico: 6jhy@163.com

Ubicaciones de estudio

  • Porcelana
    • Anhui
      • Huaibei, Anhui, Porcelana
        • Aún no reclutando
        • Anhui Wanbei Rehabilitation Hospital
        • Contacto:
    • Beijing Municipality
      • Beijing, Beijing Municipality, Porcelana, 100043
        • Reclutamiento
        • Beijing Rehabilitation Hospital, Capital Medical University, Beijing,China
        • Contacto:
          • Hong ying Jiang
          • Número de teléfono: +8601056981555
          • Correo electrónico: 6jhy@163.com
    • Hunan
      • Hunan, Hunan, Porcelana, 410000
        • Aún no reclutando
        • Hunan Rehabilitation Hospital
        • Contacto:
          • Pan Li
          • Número de teléfono: 86-18674765825
          • Correo electrónico: 584703769@qq.com
    • Zhengzhou
      • Henan, Zhengzhou, Porcelana, 450007
        • Aún no reclutando
        • Zhengzhou Central Hospital Affiliated to Zhengzhou University
        • Contacto:
          • Yajing Wang
          • Número de teléfono: 86-15515645380
          • Correo electrónico: wangya568@163.com

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Método de muestreo

Muestra de probabilidad

Población de estudio

This study is a multi-center, retrospective, observational cohort study that will enroll patients from four participating high-dependency units (HDUs) across China. Patients transferred from general hospital ICUs to the participating HDUs between January 2018 and January 2026 will be screened. Data will be sourced from medical records, nursing records, rehabilitation assessment records, and follow-up documentation from routine clinical care. The anticipated total sample size is 800 participants.

Descripción

Inclusion Criteria:

  • Age ≥18 years
  • First admission to ICU, with ICU length of stay ≥ 48 hours before transfer to HDU
  • Complete the PICS assessment within 7 days after HDU admission
  • Complete clinical data available (demographics, ICU-related information)
  • Signed informed consent obtained from participants or legal guardians

Exclusion Criteria:

  • Prior ICU admission
  • Terminal illness or estimated life expectancy <6 months
  • Participants or family members refuse to complete questionnaires

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
post-intensive care syndrome group
PICS patients who come from a general hospital ICU and are transferred to a participating HDU
Otro: Data Collection and Assessment
  1. General clinical data collection: demographic characteristics, primary disease, duration of tracheostomy tube retention, duration of mechanical ventilation before transfer, and length of ICU stay before transfer; history of organ dysfunction; tube/catheter status; disease severity; nutritional status.
  2. Physical function assessment: diaphragmatic excursion, diaphragm thickness, thickening fraction, PEF; Medical Research Council score for muscle strength, ICU Mobility Scale; comprehensive score: Chelsea Critical Care Physical Assessment Tool score.
  3. Cognitive function assessment: Standardized Five Questions，Mini-Mental State Examination.
  4. Psychological status assessment: Patient Health Questionnaire-9 for depression, Generalized Anxiety Disorder 7-item scale , Pittsburgh Sleep Quality Index, Brief Pain Inventory-9, Hospital Anxiety and Depression Scale for family caregivers.
  5. Quality of life and functional capacity: Barthel Index, EQ-5D-5L.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
MRC Sum Score for Muscle Strength
Periodo de tiempo: Collect data within 24 hours after admission to the HDU or within 24 hours before discharge from the ICU.
MRC (Medical Research Council) sum score assessing muscle strength. Total score ranges from 0 (complete quadriplegia) to 60 (normal bilateral muscle strength). Higher scores indicate better muscle strength.
Collect data within 24 hours after admission to the HDU or within 24 hours before discharge from the ICU.
ICU Mobility Scale Score
Periodo de tiempo: Collect data within 24 hours after admission to the HDU or within 24 hours before discharge from the ICU.
ICU Mobility Scale (IMS) assessing mobility level in ICU patients. Total score ranges from 0 (lying in bed, not active) to 10 (walking independently). Higher scores indicate better mobility.
Collect data within 24 hours after admission to the HDU or within 24 hours before discharge from the ICU.
Chelsea Critical Care Physical Assessment Tool Score
Periodo de tiempo: Collect data within 24 hours after admission to the HDU or within 24 hours before discharge from the ICU.
Chelsea Critical Care Physical Assessment Tool (CPAx) comprehensively evaluating physical function in ICU patients. Total score ranges from 0 to 50. Higher scores indicate better physical function.
Collect data within 24 hours after admission to the HDU or within 24 hours before discharge from the ICU.
Mini-Mental State Examination Score
Periodo de tiempo: Collect data within 24 hours after admission to the HDU or within 24 hours before discharge from the ICU.
Mini-Mental State Examination (MMSE) assessing cognitive function. Total score ranges from 0 to 30. Higher scores indicate better cognitive function. (Chinese validated version will be used.)
Collect data within 24 hours after admission to the HDU or within 24 hours before discharge from the ICU.
PHQ-9 Score for Depression
Periodo de tiempo: Collect data within 24 hours after admission to the HDU or within 24 hours before discharge from the ICU.
Patient Health Questionnaire-9 (PHQ-9) assessing severity of depressive symptoms. Total score ranges from 0 to 27 (0-4: none, 5-9: mild, 10-14: moderate, 15-19: moderately severe, 20-27: severe). Higher scores indicate worse depression.
Collect data within 24 hours after admission to the HDU or within 24 hours before discharge from the ICU.
GAD-7 Score for Anxiety
Periodo de tiempo: Collect data within 24 hours after admission to the HDU or within 24 hours before discharge from the ICU.
Generalized Anxiety Disorder 7-item scale (GAD-7) assessing severity of anxiety symptoms. Total score ranges from 0 to 21 (0-4: none, 5-9: mild, 10-14: moderate, 15-21: severe). Higher scores indicate worse anxiety.
Collect data within 24 hours after admission to the HDU or within 24 hours before discharge from the ICU.
Pittsburgh Sleep Quality Index Global Score
Periodo de tiempo: Collect data within 24 hours after admission to the HDU or within 24 hours before discharge from the ICU.
Pittsburgh Sleep Quality Index (PSQI) assessing sleep quality. Global score ranges from 0 to 21. Higher scores indicate worse sleep quality.
Collect data within 24 hours after admission to the HDU or within 24 hours before discharge from the ICU.
Brief Pain Inventory-9 Pain Severity Score
Periodo de tiempo: Collect data within 24 hours after admission to the HDU or within 24 hours before discharge from the ICU.
Brief Pain Inventory-9 (BPI-9) pain severity score. Total score ranges from 0 to 10. Higher scores indicate more severe pain.
Collect data within 24 hours after admission to the HDU or within 24 hours before discharge from the ICU.
Hospital Anxiety and Depression Scale Score for Family Caregivers
Periodo de tiempo: Collect data within 24 hours after admission to the HDU or within 24 hours before discharge from the ICU.
Hospital Anxiety and Depression Scale (HADS) assessing psychological status of family caregivers. Each subscale (anxiety and depression) ranges from 0 to 21. Higher scores indicate worse psychological distress.
Collect data within 24 hours after admission to the HDU or within 24 hours before discharge from the ICU.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Hongying Jiang, MD

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

12 de mayo de 2026

Finalización primaria (Estimado)

31 de diciembre de 2026

Finalización del estudio (Estimado)

31 de mayo de 2027

Fechas de registro del estudio

Enviado por primera vez

1 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

8 de mayo de 2026

Publicado por primera vez (Actual)

14 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

11 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

9 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 2026bkky-dzx-PICS

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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