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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032244
Receipt No. R000036756
Scientific Title The effectiveness of quick SOFA for predicting Sepsis in the unexpected critically ill patients in the hospital: A Retrospective Study
Date of disclosure of the study information 2018/04/16
Last modified on 2018/04/14

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Basic information
Public title The effectiveness of quick SOFA for predicting Sepsis in the unexpected critically ill patients in the hospital: A Retrospective Study
Acronym The effectiveness of quick SOFA for predicting Sepsis in the unexpected critically ill patients in the hospital: A Retrospective Study
Scientific Title The effectiveness of quick SOFA for predicting Sepsis in the unexpected critically ill patients in the hospital: A Retrospective Study
Scientific Title:Acronym The effectiveness of quick SOFA for predicting Sepsis in the unexpected critically ill patients in the hospital: A Retrospective Study
Region
Japan

Condition
Condition The patients received MET call
Classification by specialty
Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the possibility of suspected sepsis with quick SOFA in the patients received Met call and to reveal the relation between the abnormality of quick SOFA and mortality
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes sensitivity and specificity of diagnostic criteria with Sepsis-1 and Speis-3 in the patients meeting the quick SOFA positive and negative
Key secondary outcomes mortality(28day, 60day, 90day, hospital) in the patients meeting the quick SOFA positive and negative

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria the patients received MET call
Key exclusion criteria the patients who have insufficient data to evaluate quick SOFA
Target sample size 203

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiki Masuda
Organization Sapporo Medical University School of Medicine
Division name Department of Intensive Care Medicine
Zip code
Address West16, South1, Chuo-ku, Sapporo, Hokkaido 060-8543, Japan
TEL 011-611-2111
Email miminekko@me.com

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiki Masuda
Organization Sapporo Medical University School of Medicine
Division name Department of Intensive Care Medicine
Zip code
Address West16, South1, Chuo-ku, Sapporo, Hokkaido 060-8543, Japan
TEL 011-611-2111
Homepage URL
Email miminekko@me.com

Sponsor
Institute Sapporo Medical University
Institute
Department

Funding Source
Organization Sapporo Medical University
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
Email

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 04 Month 16 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2017 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 31 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We have already analyzed the data.

Management information
Registered date
2018 Year 04 Month 14 Day
Last modified on
2018 Year 04 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036756

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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