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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027258
Receipt No. R000031224
Scientific Title A multicenter, prospective study to validate sepsis prognostication models in the emergency room
Date of disclosure of the study information 2017/06/01
Last modified on 2018/05/17

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Basic information
Public title A multicenter, prospective study to validate sepsis prognostication models in the emergency room
Acronym SPICE (Sepsis Prognostication in Intensive Care Unit and Emergency Room)
Scientific Title A multicenter, prospective study to validate sepsis prognostication models in the emergency room
Scientific Title:Acronym SPICE (Sepsis Prognostication in Intensive Care Unit and Emergency Room)
Region
Japan

Condition
Condition Infectious disease
Classification by specialty
Medicine in general Infectious disease Emergency medicine
Intensive care medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare prognostication models for predicting
mortality in emergency room patients with infectious disease.
Basic objectives2 Others
Basic objectives -Others To externally validate the prognostication models.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Mortality in the emergency room or during hospitalization
Key secondary outcomes

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
999 years-old >=
Gender Male and Female
Key inclusion criteria All patients who presented to the emergency room with a clinically suspected infectious disease or who were diagnosed with an infectious disease by a treating emergency physician, and who underwent at least one of the following : treatment for infection, a microbiological investigation and/or a radiological investigation due to infection.
Key exclusion criteria Patients were excluded if they had been registered once, had recurrent infection or were not eligible for aggressive care.
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoshi Gando
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 Shuuta Fukuda
Organization Japanese Association for Acute Medicine
Division name Japanese Association for Acute Medicine
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
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
2017 Year 06 Month 01 Day

Related information
URL releasing protocol
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 Completed
Date of protocol fixation
2017 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
2018 Year 02 Month 13 Day
Date trial data considered complete
2018 Year 05 Month 22 Day
Date analysis concluded

Other
Other related information This study compared prognostication ability for ER or hospital mortality between SIRS and qSOFA.

Management information
Registered date
2017 Year 05 Month 06 Day
Last modified on
2018 Year 05 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031224

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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