UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006193 |
|---|---|
| Receipt number | R000007325 |
| Scientific Title | Analysis of various laboratory data of sepsis patients in the intensive care unit: a multicenter observational study |
| Date of disclosure of the study information | 2011/08/25 |
| Last modified on | 2011/08/18 15:56:25 |
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Basic information
Public title
Analysis of various laboratory data of sepsis patients in the intensive care unit: a multicenter observational study
Acronym
Analysis of various laboratory data of sepsis patients in the intensive care unit
Scientific Title
Analysis of various laboratory data of sepsis patients in the intensive care unit: a multicenter observational study
Scientific Title:Acronym
Analysis of various laboratory data of sepsis patients in the intensive care unit
Region
| Japan |
Condition
Condition
Sepsis
Classification by specialty
| Infectious disease | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the possibility as predictor of pathology of sepsis by conducting blood coagulation test, hematologic test and biochemical test on sepsis patients
Basic objectives2
Others
Basic objectives -Others
Epidemiological study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Assessment of test data usage in the ICU
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Sepsis patients who are in the ICU of participating facilities on observation day
Key exclusion criteria
Patients who expressed their will not participate in
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | TOSHIAKI IKEDA |
Organization
Tokyo Medical University Hachioji Medical Center
Division name
Department of Critical Care Medicine
Zip code
Address
Tate-machi,Hachioji,Tokyo/Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | TOSHIAKI IKEDA |
Organization
Tokyo Medical University Hachioji Medical Center
Division name
Department of Critical care Medicine
Zip code
Address
TEL
Homepage URL
tokyo_ikeda@yahoo.co.jp
Sponsor or person
Institute
Tokyo Medical University Hachioji Medical Center
Institute
Department
Personal name
Funding Source
Organization
none
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
日本大学医学部附属病院（東京都）、東京女子医科大学医学部附属病院（東京都）、東京医科大学附属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 08 | Month | 25 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 01 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective cohort
Management information
Registered date
| 2011 | Year | 08 | Month | 18 | Day |
Last modified on
| 2011 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007325
