UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042272 |
|---|---|
| Receipt number | R000048219 |
| Scientific Title | Post intensive care syndrome in critically ill patients: An observational study |
| Date of disclosure of the study information | 2020/10/28 |
| Last modified on | 2024/05/01 13:27:25 |
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Basic information
Public title
Post intensive care syndrome in critically ill patients: An observational study
Acronym
Post intensive care syndrome in critically ill patients: An observational study
Scientific Title
Post intensive care syndrome in critically ill patients: An observational study
Scientific Title:Acronym
Post intensive care syndrome in critically ill patients: An observational study
Region
| Japan |
Condition
Condition
1. sepsis, 2. resuscitation from out-of-hospital cardiac arrest, 3. severe burn, and 4. trauma
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify long-term physical, cognitive and mental function, the activity of daily living, and quality of life (post-ICU syndrome) in critically ill patients after the discharge of the intensive care unit.
Basic objectives2
Others
Basic objectives -Others
Descriptive
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1). Short Form-36
2). Euro QOL
3). Mini Mental State Examination (MMSE)
4). Hospital Anxiety and Depression Scale (HADS) and K6 for emotional disorder and anxiety
until two years of hospital discharge (at 6, 12, 18, and 24 months after discharge).
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. The patients with sepsis, resuscitated out-of-hospital cardiac arrest, severe burn, or trauma admitted to the intensive care unit of Tohoku University Hospital.
2. These patients who are survived at discharge and expected to be independent or slight disability at home and come to the outpatient.
Key exclusion criteria
1. Less than 18 years old
2. Not severe patients
3. Patients who are not survived at discharge
4. The patients who are not able to come outpatient because of moderate or severe disability
5. The patients who are not able to come to the outpatient within one year after discharge for any reason.
6. The patients who died within one year after discharge.
7. The patients who do not consent to participate in the study
8. The patients whom the attending physician decided not to enroll in the study for the other reasons
Target sample size
145
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Kudo |
Organization
Tohoku University Graduate School of Medicine
Division name
Division of Emergency and Critical Care Medicine
Zip code
9808574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai
TEL
0227177489
daisuke.kudo.b3@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Kudo |
Organization
Tohoku University Graduate School of Medicine
Division name
Division of Emergency and Critical Care Medicine
Zip code
9808574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai
TEL
0227177489
Homepage URL
daisuke.kudo.b3@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai
Tel
022-717-8007
med-kenkyo@grp.tohoku.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
東北大学病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 10 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 09 | Month | 16 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a single-center observational study.
Management information
Registered date
| 2020 | Year | 10 | Month | 28 | Day |
Last modified on
| 2024 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048219
