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NCT Number: NCT07193797

Delirium Phenotypes and Subsequent Impairment During Transition From ICU to Hospital Wards

The goal of this observational study is to learn about the disability profile during transition from ICU to hospital wards of delirium patients, including cognitive impairment, physical dysfunction and psychological disorders. The main question it aims to answer is:

* What is the main rehabilitation problem during transition from ICU to hospital wards for patients who experienced ICU delirium? * Dose different phenotypes of ICU delirium shows different rehabilitation problem during ICU transition? Participants will be followed up and assessed by questionnaires after discharge from ICU to hospital wards until hospital discharge.

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Key information

Conditions

Delirium Cognition Disorders Cognitive Dysfunction Confusion Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Post ICU Syndrome Signs and Symptoms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location status: Recruiting

Location contact

Shining Cai

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients aged above 18-year-old
  • at least one positive screening of CAM-ICU (Confusion Assessment Method for ICU) assessment during ICU stay
  • patients are transferred to hospital ward after ICU discharge

Exclusion criteria

  • patients are with severe dementia
  • blindness, deafness or inability to understand mandarin
  • life expectancy of less than 24h
  • stayed in ICU more than one-month after the first CAM-ICU positive screening

Treatment and study plan

Phenotypes of ICU delirium

Other

The included delirium patients will be divided into different phenotypes, according to delirium risk factors such as age, history of cerebrovascular accident, blood transfusion, surgery duration etc.

Primary outcomes

  1. Physical impairment

    Time frame: At first, third day and fifth day after ICU discharge, at the 1 day of hospital discharge, one-month after hospital discharge

    The Modified Barthel Index is a widely used scale for assessing a patient's level of independence in activities of daily living (ADLs). Each activity is scored based on the degree of assistance required, with total scores typically ranging from 0 (complete dependence) to 100 (complete independence).

  2. Cognitive impairment

    Time frame: At first, third day and fifth day after ICU discharge, at the 1 day of hospital discharge, one-month after hospital discharge

    The Mini-MoCA (Mini Montreal Cognitive Assessment) is a brief cognitive screening tool derived from the full MoCA, designed to rapidly assess cognitive function in clinical and hospital settings. It evaluates key domains such as orientation, attention, memory, language, and visuospatial skills, using a condensed format suitable for bedside.

  3. Mental health

    Time frame: At first, third day and fifth day after ICU discharge, at the 1 day of hospital discharge, one-month after hospital discharge

    Hospital Anxiety and Depression Scale(HADS) is a 14-item tool used to screen for anxiety and depression in hospitalised patients. It includes two 7-item subscales, each scored 0-21, with higher scores indicate more severe psychological distress.

Secondary outcomes

  1. Hospital stay

    Time frame: up to 30 days

    Duration of hospital stay

  2. In-hospital Mortality

    Time frame: up to 30 days

    Mortality during hospital stay

Study contacts

Contact information is provided by the study sponsor or research team.

Shining CAI, PhD

CONTACT

[email protected]

8618818260719

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Collaborators

  • National Natural Science Foundation of China

Registry information

Official study title

Clinical Phenotypes of ICU Delirium and Subsequent Impairment of Physical, Cognitive and Mental Health During Transition From ICU to Hospital Wards

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 26, 2025
Registry last updated
Sep 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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