UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A multicenter, prospective study to validate sepsis prognostication models in the emergency room
Title of the study (Brief title)	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	Satoshi Gando
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	Shuuta Fukuda
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
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 06 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000031224