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Recruiting NCT07585578

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

— Observational Post-Intensive Care Syndrome (PICS)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Data Collection and Assessment.
Who it may be relevant to
Registry conditions: Post-Intensive Care Syndrome (PICS). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Other 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 sco

Primary outcome measures

  • MRC Sum Score for Muscle Strength [Time frame: Collect data within 24 hours after admission to the HDU or within 24 hours before discharge from the ICU.]
  • ICU Mobility Scale Score [Time frame: 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 [Time frame: Collect data within 24 hours after admission to the HDU or within 24 hours before discharge from the ICU.]
  • Mini-Mental State Examination Score [Time frame: Collect data within 24 hours after admission to the HDU or within 24 hours before discharge from the ICU.]
  • PHQ-9 Score for Depression [Time frame: Collect data within 24 hours after admission to the HDU or within 24 hours before discharge from the ICU.]
  • GAD-7 Score for Anxiety [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: Collect data within 24 hours after admission to the HDU or within 24 hours before discharge from the ICU.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 4 centers
  • Anhui Wanbei Rehabilitation Hospital — Huaibei
  • Beijing Rehabilitation Hospital, Capital Medical University, Beijing,China — Beijing
  • Hunan Rehabilitation Hospital — Hunan
  • Zhengzhou Central Hospital Affiliated to Zhengzhou University — Henan

Identifiers

NCT: NCT07585578 · 2026bkky-dzx-PICS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗