Critical IllnessNCT07585578
Multidimensional Dysfunction in Patients With Chronic Critical Illness in China
An observational study of Critical Illness, run by Hongying Jiang, MD at 4 sites in China.
Trial summary
Over the past two decades, rapid advances in critical care medicine have markedly reduced short-term mortality among critically ill patients. As a result, a growing number of patients survive the acute phase of critical illness but do not recover quickly. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- Data Collection and Assessment
- How many people
- 888 participants
- Where
- 4 sitesChina
- Study dates
- 31 Jan 2018to 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This multicenter retrospective cross-sectional observational study included consecutive adults with chronic critical illness (CCI) transferred from ICUs to four participating high-dependency units (HDUs) in China between January 2018 and January 2026. CCI was defined as a post-ICU state in which patients no longer required full ICU-level care but remained clinically dependent, required continued HDU treatment, and could not be discharged directly home or return to community living. Data were obtained from routine medical, nursing, rehabilitation, and clinical records. Cognitive, physical, and psychological assessments were completed within 7 days of HDU admission, and family caregivers were assessed using the Hospital Anxiety and Depression Scale.
Who may be able to join
- Adults aged 18 years or older.
- Patients with chronic critical illness (CCI), operationally defined as patients transferred from an intensive care unit (ICU) to a participating high-dependency unit (HDU) who no longer required full ICU-level care but remained clinically dependent, required continued inpatient treatment in an HDU, and could not be discharged directly home or return to community living.
- Completion of cognitive, physical, and psychological assessments within 7 days after HDU admission.
Who cannot join
- No identifiable family caregiver available to complete the Hospital Anxiety and Depression Scale assessment.
- A documented diagnosis of dementia or a chronic psychiatric disorder requiring continuous pharmacological treatment before the index ICU admission.
- Admission to the HDU exclusively for end-of-life or palliative care.
Trial locations and contacts
4 sites in 1 country.
China4 sites
Beijing Rehabilitation Hospital, Capital Medical University, Beijing,China
Beijing, Beijing Municipality, 100043
Zhengzhou Central Hospital Affiliated to Zhengzhou University
Henan, Zhengzhou, 450007
Anhui Wanbei Rehabilitation Hospital
Huaibei, Anhui
Hunan Rehabilitation Hospital
Hunan, Hunan, 410000
About this study
Official title: Multidimensional Dysfunction in Patients With Chronic Critical Illness in China: A Multi-center Real-world Study
Over the past two decades, rapid advances in critical care medicine have markedly reduced short-term mortality among critically ill patients. As a result, a growing number of patients survive the acute phase of critical illness but do not recover quickly. Instead, they develop chronic critical illness (CCI), which is characterized by prolonged dependence on intensive care, including prolonged mechanical ventilation, persistent organ dysfunction, recurrent infections, and extended intensive care unit (ICU) stay. Patients with CCI have a heavy symptom burden and consume substantial healthcare resources, and many survivors experience persistent physical, cognitive, and psychological impairments after hospital discharge. Although CCI has gained increasing attention in recent years, existing studies still have multiple limitations. The number of patients with CCI in China continues to rise, and critical care delivery models vary widely across regions and healthcare institutions. There is therefore an urgent need for a large-scale multicenter observational study to systematically characterize the epidemiological features, multidimensional functional impairment profiles, and long-term functional outcomes of Chinese patients with CCI. The findings will provide an evidence-based foundation for developing a scientific post-ICU continuum of care for this population.
Read the detailed description
This multicenter retrospective cross-sectional study included 888 consecutive adult patients with CCI admitted to four participating high-dependency units (HDUs) between January 2018 and January 2026, using data from routine clinical assessments. 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 physical, cognitive, and psychological impairments and their co-occurrence patterns across functional domains in patients with CCI. The secondary outcomes include functional status, quality of life, and risk factors for functional impairment.
- Conditions
- Critical Illness
- Being tested
- Data Collection and Assessment
- Keywords
- Critical Illness, High-dependency unit, functional outcome
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data Collection and AssessmentOther
- 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.
- 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.
- Cognitive function assessment: Standardized Five Questions，Mini-Mental State Examination.
- 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.
- Quality of life and functional capacity: Barthel Index, EQ-5D-5L.
| Study group | Role | What they receive |
|---|---|---|
| Patients With Chronic Critical Illness | Adult patients with chronic critical illness (CCI) admitted to four participating high-dependency units (HDUs) in China. Receives: Other: Data Collection and Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRC Sum Score for Muscle Strength
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.
Measured: Within 7 days after HDU admission
ICU Mobility Scale Score
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.
Measured: Within 7 days after HDU admission
Chelsea Critical Care Physical Assessment Tool Score
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.
Measured: Within 7 days after HDU admission
Mini-Mental State Examination Score
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.)
Measured: Within 7 days after HDU admission
PHQ-9 Score for Depression
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.
Measured: Within 7 days after HDU admission
GAD-7 Score for Anxiety
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.
Measured: Within 7 days after HDU admission
Pittsburgh Sleep Quality Index Global Score
Pittsburgh Sleep Quality Index (PSQI) assessing sleep quality. Global score ranges from 0 to 21. Higher scores indicate worse sleep quality.
Measured: Within 7 days after HDU admission
Brief Pain Inventory-9 Pain Severity Score
Brief Pain Inventory-9 (BPI-9) pain severity score. Total score ranges from 0 to 10. Higher scores indicate more severe pain.
Measured: Within 7 days after HDU admission
Hospital Anxiety and Depression Scale Score for Family Caregivers
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.
Measured: Within 7 days after HDU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start31 Jan 2018
- Primary completion31 Jan 2026
- 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 Critical IllnessStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 888 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hongying Jiang, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hongying Jiang, MD, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07585578
- Sponsor's protocol ID
- 2026bkky-dzx-CCI
- Status last verified
- Oct 2026
- First submitted
- 1 May 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidimensional Dysfunction in Patients With Chronic Critical Illness in China: A Multi-center Real-world Study
- ClinicalTrials.gov ID
- NCT07585578
- Acronym / sponsor ID
- 2026bkky-dzx-CCI
- Conditions
- Critical Illness
- Keywords
- Critical Illness, High-dependency unit, functional outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 888 participants (actual)
- Lead sponsor
- Hongying Jiang, MDUniversity, hospital or other
- Study start
- 31 Jan 2018 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 14 May 2026 (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.
Over the past two decades, rapid advances in critical care medicine have markedly reduced short-term mortality among critically ill patients. As a result, a growing number of patients survive the acute phase of critical illness but do not recover quickly. Instead, they develop chronic critical illness (CCI), which is characterized by prolonged dependence on intensive care, including prolonged mechanical ventilation, persistent organ dysfunction, recurrent infections, and extended intensive care unit (ICU) stay. Patients with CCI have a heavy symptom burden and consume substantial healthcare resources, and many survivors experience persistent physical, cognitive, and psychological impairments after hospital discharge. Although CCI has gained increasing attention in recent years, existing studies still have multiple limitations. The number of patients with CCI in China continues to rise, and critical care delivery models vary widely across regions and healthcare institutions. There is therefore an urgent need for a large-scale multicenter observational study to systematically characterize the epidemiological features, multidimensional functional impairment profiles, and long-term functional outcomes of Chinese patients with CCI. The findings will provide an evidence-based foundation for developing a scientific post-ICU continuum of care for this population.
Detailed description
This multicenter retrospective cross-sectional study included 888 consecutive adult patients with CCI admitted to four participating high-dependency units (HDUs) between January 2018 and January 2026, using data from routine clinical assessments. 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 physical, cognitive, and psychological impairments and their co-occurrence patterns across functional domains in patients with CCI. The secondary outcomes include functional status, quality of life, and risk factors for functional impairment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients With Chronic Critical Illness | – | Other: Data Collection and AssessmentAdult patients with chronic critical illness (CCI) admitted to four participating high-dependency units (HDUs) in China. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This multicenter retrospective cross-sectional observational study included consecutive adults with chronic critical illness (CCI) transferred from ICUs to four participating high-dependency units (HDUs) in China between January 2018 and January 2026. CCI was defined as a post-ICU state in which patients no longer required full ICU-level care but remained clinically dependent, required continued HDU treatment, and could not be discharged directly home or return to community living. Data were obtained from routine medical, nursing, rehabilitation, and clinical records. Cognitive, physical, and psychological assessments were completed within 7 days of HDU admission, and family caregivers were assessed using the Hospital Anxiety and Depression Scale.
Key inclusion criteria (3 listed)
- Adults aged 18 years or older.
- Patients with chronic critical illness (CCI), operationally defined as patients transferred from an intensive care unit (ICU) to a participating high-dependency unit (HDU) who no longer required full ICU-level care but remained clinically dependent, required continued inpatient treatment in an HDU, and could not be discharged directly home or return to community living.
- Completion of cognitive, physical, and psychological assessments within 7 days after HDU admission.
Key exclusion criteria (3 listed)
- No identifiable family caregiver available to complete the Hospital Anxiety and Depression Scale assessment.
- A documented diagnosis of dementia or a chronic psychiatric disorder requiring continuous pharmacological treatment before the index ICU admission.
- Admission to the HDU exclusively for end-of-life or palliative care.
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 |
|---|---|---|
| Data Collection and Assessment1. 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. | Other | Patients With Chronic Critical Illness |
Primary outcome
MRC Sum Score for Muscle Strength
Time frame: Within 7 days after HDU admission
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.
ICU Mobility Scale Score
Time frame: Within 7 days after HDU admission
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.
Chelsea Critical Care Physical Assessment Tool Score
Time frame: Within 7 days after HDU admission
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.
Mini-Mental State Examination Score
Time frame: Within 7 days after HDU admission
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.)
PHQ-9 Score for Depression
Time frame: Within 7 days after HDU admission
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.
GAD-7 Score for Anxiety
Time frame: Within 7 days after HDU admission
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.
Pittsburgh Sleep Quality Index Global Score
Time frame: Within 7 days after HDU admission
Pittsburgh Sleep Quality Index (PSQI) assessing sleep quality. Global score ranges from 0 to 21. Higher scores indicate worse sleep quality.
Brief Pain Inventory-9 Pain Severity Score
Time frame: Within 7 days after HDU admission
Brief Pain Inventory-9 (BPI-9) pain severity score. Total score ranges from 0 to 10. Higher scores indicate more severe pain.
Hospital Anxiety and Depression Scale Score for Family Caregivers
Time frame: Within 7 days after HDU admission
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.
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 22 Oct 2026.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness, run by Hongying Jiang, MD at 4 sites 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 3 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 22 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 4 sites 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?
MRC Sum Score for Muscle Strength (time frame: Within 7 days after HDU admission). The study lists 9 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 22 Oct 2026.