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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027452
Receipt No. R000031451
Scientific Title A multicenter, prospective, validation study for mew sepsis definition in intensive care unit
Date of disclosure of the study information 2017/06/01
Last modified on 2017/05/22

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Basic information
Public title A multicenter, prospective, validation study for mew sepsis definition in intensive care unit
Acronym New sepsis definition in ICU
JAAM SPICE study
Scientific Title A multicenter, prospective, validation study for mew sepsis definition in intensive care unit
Scientific Title:Acronym New sepsis definition in ICU
JAAM SPICE study
Region
Japan

Condition
Condition Sepsis
Classification by specialty
Emergency medicine Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate discriminatory capacities of SIRS, qSOFA, and SOFA for outcome among patients who are suspected infection in Intensive Care Unit
Basic objectives2 Others
Basic objectives -Others 28-day and hospital mortality
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Hospital mortality (survival, death)
Key secondary outcomes 1. 28-day mortality
2. Validation of SIRS, qSOFA, and SOFA for characteristics of sepsis diagnosis
3.Ventilator free day, ICU free days
4.Validation of SOFA score

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 All patients who presented in ICU with a clinical suspicion of infection diagnosed by treating emergency physicians or intensivists, followed by the orders to explore origins or organisms of the infection by cultures or radiological images, or beginning of the treatments for infection.
Key exclusion criteria Patients with recurrent infection.
Patients who accepted DNAR orders.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name GANDO Satoshi
Organization Hokkaido University Graduate School of Medicine
Division name Acute and Critical Care Medicine
Zip code
Address N15W7, Kita-ku, Sapporo
TEL +81-11-706-7377
Email gando@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name FUKUDA shuta
Organization Japanese Association for Acute Medicine
Division name Head office
Zip code
Address 3-3-12, Hongo, Bunkyo-ku, Tokyo
TEL +81-3-5840-9870
Homepage URL
Email jaam-6@bz04.plala.or.jp

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 Government offices of other countries
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
2017 Year 06 Month 01 Day

Related information
URL releasing protocol http://www.jaam.jp/html/jaamforecast/index.html
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 Open public recruiting
Date of protocol fixation
2017 Year 03 Month 22 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Only those used in general practice

Management information
Registered date
2017 Year 05 Month 22 Day
Last modified on
2017 Year 05 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031451

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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