UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012543 |
|---|---|
| Receipt number | R000014572 |
| Scientific Title | Japan septic disseminated intravascural cogulation (DIC) study |
| Date of disclosure of the study information | 2014/01/01 |
| Last modified on | 2015/12/17 00:26:11 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Japan septic disseminated intravascural cogulation (DIC) study
Acronym
J-SEPTIC DIC study
Scientific Title
Japan septic disseminated intravascural cogulation (DIC) study
Scientific Title:Acronym
J-SEPTIC DIC study
Region
| Japan |
Condition
Condition
severe sepsis / septic shock
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate treatments for septic disseminated intravascular coagulation (DIC).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
In-hospital mortality
ICU mortality
Length of ICU stay
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients with severe sepsis/septic shock admitted to ICU from January 1, 2011 to December 31, 2013.
Key exclusion criteria
Not applicable
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mineji Hayakawa |
Organization
Hokkaido University Hospital
Division name
Emergency and Critical Care Center
Zip code
Address
N14W5, Kita-ku, Sapporo
TEL
011-737-8312
mineji@dream.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mineji Hayakawa |
Organization
Hokkaido University Hospital
Division name
Emergency and Critical Care Center
Zip code
Address
N14W5, Kita-ku, Sapporo
TEL
011-737-8312
Homepage URL
mineji@dream.com
Sponsor or person
Institute
Emergency and Critical Care Cente
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japanese Society of Education for Physicians and Trainees in Intensive Care
Organization
Division
Category of Funding Organization
Other
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
| 2014 | Year | 01 | 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
| 2013 | Year | 11 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2015 | Year | 09 | Month | 08 | Day |
Date analysis concluded
Other
Other related information
Multicenter retrospective observational study
Management information
Registered date
| 2013 | Year | 12 | Month | 10 | Day |
Last modified on
| 2015 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014572
| Research Plan | |
|---|---|
| Registered date | File name |
| 2016/06/02 | ⑧北大倫理委員会 後向き研究計画書.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2016/06/02 | ③入力要綱.docx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2016/06/02 | Data_comp150908.xlsx |
Single case data URL
Value
https://center6.umin.ac.jp/ice/14572
