UMIN-CTR Clinical Trial

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 Satoshi Middle name Last name GANDO
Organization	Hokkaido University Graduate School of Medicine
Division name	Acute and Critical Care Medicine
Zip code	060-0815
Address	N15W7, Kita-ku, Sapporo
TEL	+81-11-706-7377
Email	gando@med.hokudai.ac.jp

Public contact
Name of contact person	1st name shuta Middle name Last name FUKUDA
Organization	Japanese Association for Acute Medicine
Division name	Head office
Zip code	113-0033
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	Hokkaido University Hospital Clinical Research and Medical Innovation Center
Address	N14W5, Kita-ku, Sapporo
Tel	+81-11-701-7636
Email	crjimu@huhp.hokudai.ac.jp

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	Main results already published
Date of protocol fixation	2017 Year 03 Month 22 Day
Date of IRB	2017 Year 02 Month 08 Day
Anticipated trial start date	2017 Year 08 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
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	2021 Year 03 Month 27 Day

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