UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030471 |
|---|---|
| Receipt number | R000034662 |
| Scientific Title | Frequency and the risk factors of ICU-AW after critical illness |
| Date of disclosure of the study information | 2017/12/19 |
| Last modified on | 2017/12/21 13:36:08 |
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Basic information
Public title
Frequency and the risk factors of ICU-AW after critical illness
Acronym
Frequency and the risk factors of ICU-AW after critical illness
Scientific Title
Frequency and the risk factors of ICU-AW after critical illness
Scientific Title:Acronym
Frequency and the risk factors of ICU-AW after critical illness
Region
| Japan |
Condition
Condition
ICU acquired weakness
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the frequency and prognosis of ICU-AW in critically ill patients admitted to ICU
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the rate of ICU-AW and the time when nerve conduction study has changed
Key secondary outcomes
prognosis(ICU, 28day, 90day, hospital mortality)
inflamatory biomarker(CRP, Procalcitonin, Presepsin)
Plasma cytokine(IL-1, IL-4, IL-6, IL-8, IL-10, IFN-gamma, TNF-alpha)
Steroid, Immunoglobulin, Sedatives
day of the beginning of rehabilitation, period of rehabilitation
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
The patients with mechanical ventilation
over 18 years old
over 24 hours length of stay of ICU
The patiens with highly invasive or organ failure due to infection
The patient who got agreement on this study
Key exclusion criteria
The patients who didn't got agreement on this study
The patients judged as inappropriate enrollment
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayuki Akatsuka |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Intensive Care Medicine
Zip code
Address
South1 West16, Chuo-ku, Sapporo
TEL
011-611-2111
m_a_let_go@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masayuki Akatsuka |
Organization
Sapporo Medical University School of Medicene
Division name
Department of Intensive Care Medicine
Zip code
Address
South1 West16, Chuo-ku, Sapporo
TEL
011-611-2111
Homepage URL
m_a_let_go@yahoo.co.jp
Sponsor or person
Institute
Sapporo Medical University School of Medicene, Department of Intensive Care Medicine
Institute
Department
Personal name
Funding Source
Organization
Sapporo Medical University School of Medicene, Department of Intensive Care Medicine
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
Address
Tel
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
| 2017 | Year | 12 | Month | 19 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 09 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 12 | Month | 18 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Investigation of the timing of abnormalities of nerve conduction study in the patients with ICU-AW and clarification of the risk factors.
Management information
Registered date
| 2017 | Year | 12 | Month | 19 | Day |
Last modified on
| 2017 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034662
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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