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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033654
Receipt No. R000038369
Official scientific title of the study Frailty assessment using CT for prognosis prediction in septic elderly patients; multi-institutional retrospective cohort study
Date of disclosure of the study information 2018/08/10
Last modified on 2018/08/07

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Basic information
Official scientific title of the study Frailty assessment using CT for prognosis prediction in septic elderly patients; multi-institutional retrospective cohort study
Title of the study (Brief title) Frailty assessment using CT for prognosis prediction in septic elderly patients; multi-institutional retrospective cohort 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 elderly 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
60 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria > =60y.o
Emergent ICU admission to treat sepsis
Key exclusion criteria No CT imagines before and after ICU admission
Unmeasurable of frail component by CT
Opt-out
Target sample size 320

Research contact person
Name of lead principal investigator Kaoru Koike
Organization Graduate school of medicine, Kyoto university
Division name Department of primary care and emergency medicine
Address 54, Syougoin Kawaramachi, Sakyou, Kyoto, Japan
TEL 075-751-3126
Email qqinfo@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person Yohei Okada
Organization Graduate school of medicine, Kyoto university
Division name Department of primary care and emergency medicine
Address 54, Syougoin Kawaramachi, Sakyou, Kyoto, Japan
TEL 075-751-3126
Homepage URL
Email okada.yohei.48x@st.kyoto-u.ac.jp

Sponsor
Institute Graduate school of medicine, Kyoto University
Institute
Department

Funding Source
Organization Applying Daiwa securities health foundation
(If not, No funding source)
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 08 Month 15 Day
Anticipated trial start date
2018 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information Osteopenia and sarcopenic findings are measured by CT

Management information
Registered date
2018 Year 08 Month 07 Day
Last modified on
2018 Year 08 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038369

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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