UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A multicenter, prospective observational study for the epidemiology of severe sepsis
Title of the study (Brief title)	Epidemiology of severe sepsis
Region	Japan

Condition
Condition	severe sepsis
Classification by specialty	Emergency medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to investigate the epidemiology of severe sepsis, to elucidate the pathogenesis of organ dysfunction in severe sepsis and to establish the diagnosis and therapeutic methods for severe sepsis.
Basic objectives2	Others
Basic objectives -Others	28-day and hospital mortality
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The epidemiology of severe sepsis (hospital mortality).
Key secondary outcomes	1. The pathophysiology of severe sepsis and pathogenesis of organ dysfunction in severe sepsis. 2. The diagnosis and treatment of severe sepsis.

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	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who met the definition of severe sepsis according to SCCM/ACCP 1992, SCC/ESICM/ACCP/ATS/SIS 2003 and SSCG 2012.
Key exclusion criteria	None.
Target sample size	613

Research contact person
Name of lead principal investigator	GANDO Satoshi
Organization	Hokkaido University Graduate School of Medicine
Division name	Acute and Critical Care Medicine
Address	N15W7, Kita-ku, Sapporo
TEL	+81-11-706-7377
Email	gando@med.hokudai.ac.jp

Public contact
Name of contact person	SATO Kiyohiko
Organization	Japanese Association for Acute Medicine
Division name	Japanese Association for Acute Medicine
Address	3-3-12, Hongo, Bunkyo-ku, Tokyo
TEL	+81-3-5840-9870
Homepage URL	http://www.jaam.jp/html/jaamforecast/index.html
Email	editorial-jaam@umin.net

Sponsor
Institute	Japanese Association for Acute Medicine
Institute
Department

Funding Source
Organization	Japanese Association for Acute Medicine, Japan Society for the Promotion of the Science
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

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	2015 Year 11 Month 16 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 06 Month 05 Day
Anticipated trial start date	2016 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry	2017 Year 05 Month 08 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol	http://www.jaam.jp/html/jaamforecast/index.html
Publication of results	Unpublished
URL releasing results
Results
Other related information	The epidemiology of severe sepsis, the pathogenesis of organ dysfunction in severe sepsis and the diagnosis and therapeutic methods for severe sepsis. Study design: Prospective cohort study Patients enrollment method: Following patients are eligible for the study. Patients present to emergency department from January to December 2016 and meet the entry criteria Measurement variables: DIC score, SOFA score, SIRS score, APACHE score etc.

Management information
Registered date	2015 Year 11 Month 11 Day
Last modified on	2017 Year 05 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022802