UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045737 |
|---|---|
| Receipt number | R000051351 |
| Scientific Title | An exploratory study of factors associated with the development of post-intensive care syndrome |
| Date of disclosure of the study information | 2021/10/12 |
| Last modified on | 2025/04/14 17:15:18 |
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Basic information
Public title
An exploratory study of factors associated with the development of post-intensive care syndrome
Acronym
An exploratory study of factors associated with the development of post-intensive care syndrome
Scientific Title
An exploratory study of factors associated with the development of post-intensive care syndrome
Scientific Title:Acronym
An exploratory study of factors associated with the development of post-intensive care syndrome
Region
| Japan |
Condition
Condition
Critical Care Medicine
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the actual condition of sleep disorders in patients after leaving the ICU and the relationship between the onset of PICS and the subsequent outcome.
Basic objectives2
Others
Basic objectives -Others
To clarify the actual condition of sleep disorders in patients after leaving the ICU and the relationship between the onset of PICS and the subsequent outcome.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Percentage of PICS 6 months after discharge of patients admitted to the ICU
Key secondary outcomes
Sleep status (objective data by brain wave measurement type sleep measurement, subjective data by questionnaire)
Onset and duration of delirium (days)
Length of stay in ICU
Number of days of hospitalization after leaving the ICU
Length of hospitalization
Scores for each scale related to physical function, depression, traumatic stress symptoms, physical symptoms, fatigue, subjective insomnia severity, and cognitive function.
Outcome after 6 months, outcome after 2 years (re-hospitalization and death)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients over 20 years of age at the time of consent
Patients who can communicate in Japanese
Patients who entered the ICU and stayed for 72 hours or more
Patients who received sufficient explanation before participating in this study, and after sufficient understanding, obtained the voluntary written consent of the patient (or a substitute if necessary).
Patients who meet all of the above are targeted.
Key exclusion criteria
Patients with advanced cognitive dysfunction
Patients with brain injury (anaerobic brain injury, stroke, traumatic brain injury) before and during ICU admission
Patients after organ transplantation
Patients expected to die within 3 months of discharge
Patients with unstable mental illness
Other patients who the principal investigator deems inappropriate as a subject
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Nomura |
Organization
Tokyo Women's Medical university
Division name
Department of Intensive Care Medicine
Zip code
162-8666
Address
8-1, Kawada-cho, Shinjuku-ku, Tokyo
TEL
03-3353-8111
tnomura@twmu.ac.jp
Public contact
Name of contact person
| 1st name | Nobuo |
| Middle name | |
| Last name | Sato |
Organization
Tokyo Women's Medical University
Division name
Department of Intensive Care Medicine
Zip code
162-8666
Address
8-1, Kawada-cho, Shinjuku-ku, Tokyo
TEL
03-3353-8111
Homepage URL
nsato-nst@umin.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Ministry of education
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Women's Medical University Ethics Review Board
Address
8-1, Kawada-cho, Shinjuku-ku, Tokyo
Tel
03-3353-8111
rinri.bm@twmu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 10 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
64
Results
The number (percentage) of patients with moderate or severe insomnia with an ISI score of 15 or higher was 1 (2.4%), 18 (44%), and 4 (9.8%) before, after, and 6 months after ICU admission, ICU discharge, and hospital discharge, respectively.
Results date posted
| 2024 | Year | 04 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Not appliciate
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 08 | Month | 11 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Not applicable
Management information
Registered date
| 2021 | Year | 10 | Month | 12 | Day |
Last modified on
| 2025 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051351
