UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033654 |
|---|---|
| Receipt number | R000038369 |
| Scientific Title | Frailty Assessment using CT for prognosis prediction in sepsis; multi-institutional retrospective cohort study |
| Date of disclosure of the study information | 2018/08/10 |
| Last modified on | 2020/03/31 14:02:33 |
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Basic information
Public title
Frailty Assessment using CT for prognosis prediction in sepsis; multi-institutional retrospective cohort study
Acronym
FACT-sepsis study
Scientific Title
Frailty Assessment using CT for prognosis prediction in sepsis; multi-institutional retrospective cohort study
Scientific Title:Acronym
FACT-sepsis study
Region
| Japan |
Condition
Condition
Sepsis
Classification by specialty
| Emergency medicine | Intensive care medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Our study aims are 1: to identify the association between osteopenia and the prognosis, 2: to confirm the association between sarcopenia and the prognosis, 3: to make the prediction model for the prognosis in septic patients.
Basic objectives2
Others
Basic objectives -Others
diagnosis
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
90 days survival/mortality
Key secondary outcomes
In-hospital mortality, ADL, Length of stay, 1-year survival
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
> =20y.o
Emergent ICU admission to treat sepsis
Key exclusion criteria
Opt-out
Target sample size
320
Research contact person
Name of lead principal investigator
| 1st name | Kaoru |
| Middle name | |
| Last name | Koike |
Organization
Graduate school of medicine, Kyoto university
Division name
Department of primary care and emergency medicine
Zip code
6068501
Address
54, Syougoin Kawaramachi, Sakyou, Kyoto, Japan
TEL
075-751-3126
qqinfo@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Yohei |
| Middle name | |
| Last name | Okada |
Organization
Graduate school of medicine, Kyoto university
Division name
Department of primary care and emergency medicine
Zip code
606-8501
Address
54, Syougoin Kawaramachi, Sakyou, Kyoto, Japan
TEL
075-751-3126
Homepage URL
okada.yohei.48x@st.kyoto-u.ac.jp
Sponsor or person
Institute
Graduate school of medicine, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
No
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
Kyoto University
Address
same as above
Tel
same as above
same as above
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
| 2018 | Year | 08 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 10 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Frail assessment by CT
Management information
Registered date
| 2018 | Year | 08 | Month | 07 | Day |
Last modified on
| 2020 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038369
| 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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| Registered date | File name |
