UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027452 |
|---|---|
| Receipt number | 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 | 2021/03/27 09:12:26 |
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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 | 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
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
jaam-6@bz04.plala.or.jp
Sponsor or person
Institute
Japanese Association for Acute Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031451
