UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effectiveness of quick SOFA for predicting Sepsis in the unexpected critically ill patients in the hospital: A Retrospective Study
Title of the study (Brief title)	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	Yoshiki Masuda
Organization	Sapporo Medical University School of Medicine
Division name	Department of Intensive Care Medicine
Address	West16, South1, Chuo-ku, Sapporo, Hokkaido 060-8543, Japan
TEL	011-611-2111
Email	miminekko@me.com

Public contact
Name of contact person	Yoshiki Masuda
Organization	Sapporo Medical University School of Medicine
Division name	Department of Intensive Care Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 12 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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