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Recruitment status Main results already published
Unique ID issued by UMIN UMIN000010297
Receipt No. R000012055
Scientific Title Tohoku Sepsis Registry: from Acute Phase to Long-Term Surveillance
Date of disclosure of the study information 2013/09/01
Last modified on 2018/03/26

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Basic information
Public title Tohoku Sepsis Registry: from Acute Phase to Long-Term Surveillance
Acronym Tohoku Sepsis Registry
Scientific Title Tohoku Sepsis Registry: from Acute Phase to Long-Term Surveillance
Scientific Title:Acronym Tohoku Sepsis Registry
Region
Japan

Condition
Condition Severe sepsis
Classification by specialty
Emergency medicine Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Epidemiology of severe sepsis in Tohoku region of Japan
Basic objectives2 Others
Basic objectives -Others Epidemiology
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Prognosis of severe sepsis and international data comparison
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Fulfill diagnostic criteria proposed by ACCP/SCCM
Key exclusion criteria none
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeki Kushimoto
Organization Tohoku University Graduate School of Medicine
Division name Division of Emergency and Critical Care Medicine
Zip code
Address 2-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan
TEL 022-717-7487
Email kussie@emergency-medicine.med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shigeki Kushimoto
Organization Tohoku University Graduate School of Medicine
Division name Division of Emergency and Critical Care Medicine
Zip code
Address 2-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan
TEL 022-717-7487
Homepage URL
Email kussie@emergency-medicine.med.tohoku.ac.jp

Sponsor
Institute Division of Emergency and Critical Care Medicine, Tohoku University Graduate School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Division of Emergency and Critical Care Medicine, Tohoku University Graduate School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Tohoku Sepsis Conference
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
2013 Year 09 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2013 Year 03 Month 20 Day
Date of IRB
Anticipated trial start date
2013 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
2016 Year 03 Month 31 Day
Date trial data considered complete
2017 Year 03 Month 31 Day
Date analysis concluded
2018 Year 12 Month 31 Day

Other
Other related information Collect clinical data of severe sepsis

Management information
Registered date
2013 Year 03 Month 22 Day
Last modified on
2018 Year 03 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012055


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