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

NCT07193797 | Recruiting

• 1 other identifier: NSFC-7220040527
• Study Type: observational
• Target: 189
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Delirium; Post ICU Syndrome

Keywords

ICU delirium; Phenotypes; Physical impairment; Cognitive impairment; Mental health impairment; ICU transition

Outcome Measures

Primary Outcomes (3)

• Physical impairment

  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).

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

• Cognitive impairment

  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.

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

• Mental health

  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.

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

Secondary Outcomes (2)

• Hospital stay

  up to 30 days

• In-hospital Mortality

  up to 30 days

Study Arms (1)

ICU delirium cohort

Other: Phenotypes of ICU delirium

Interventions

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.

ICU delirium cohort

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients admitted to ICU and developed delirium will be recruited.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead
• National Natural Science Foundation of China: collaborator

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Delirium; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Central Study Contacts

Shining CAI, PhD

CONTACT

8618818260719; cai.shining@zs-hospital.sh.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2025
• First Posted: September 26, 2025
• Study Start: March 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 31, 2025
• Last Updated: September 26, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)