UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027258 |
|---|---|
| Receipt number | 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 05:23:31 |
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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
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
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031224
