DeliriumNCT07193797
Delirium Phenotypes and Subsequent Impairment During Transition From ICU to Hospital Wards
An observational study of Delirium and Post ICU Syndrome, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Delirium, Post ICU Syndrome
- What is being tested?
- Phenotypes of ICU delirium
- How many people
- 247 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to 31 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients admitted to ICU and developed delirium will be recruited.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
About this study
Official title: Clinical Phenotypes of ICU Delirium and Subsequent Impairment of Physical, Cognitive and Mental Health 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.
- Conditions
- Delirium, Post ICU Syndrome
- Being tested
- Phenotypes of ICU delirium
- Keywords
- ICU delirium, Phenotypes, Physical impairment, Cognitive impairment, Mental health impairment, ICU transition
- Medical subject headings
- Delirium, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phenotypes of ICU deliriumOther
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.
| Study group | Role | What they receive |
|---|---|---|
| ICU delirium cohort | Not described Receives: Other: Phenotypes of ICU delirium |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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
Duration of hospital stay
Measured: up to 30 days
In-hospital Mortality
Mortality during hospital stay
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start1 Mar 2024
- Primary completion1 Dec 2025
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 247 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07193797
- Sponsor's protocol ID
- NSFC-7220040527
- Status last verified
- Oct 2026
- First submitted
- 12 Jan 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Phenotypes of ICU Delirium and Subsequent Impairment of Physical, Cognitive and Mental Health During Transition From ICU to Hospital Wards
- ClinicalTrials.gov ID
- NCT07193797
- Acronym / sponsor ID
- NSFC-7220040527
- Conditions
- Delirium, Post ICU Syndrome
- Keywords
- ICU delirium, Phenotypes, Physical impairment, Cognitive impairment, Mental health impairment, ICU transition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 247 participants (actual)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 26 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICU delirium cohort | – | Other: Phenotypes of ICU delirium |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted to ICU and developed delirium will be recruited.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phenotypes of ICU deliriumThe 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. | Other | ICU delirium cohort |
Primary outcome
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).
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.
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.
2 secondary outcomes
Hospital stay
Time frame: up to 30 days
In-hospital Mortality
Time frame: up to 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium and Post ICU Syndrome, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.