UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011036 |
|---|---|
| Receipt number | R000012913 |
| Scientific Title | Long-term physical, cognitive and Quality-of-Life outcome and their risk factors in severe sepsis |
| Date of disclosure of the study information | 2013/09/01 |
| Last modified on | 2013/06/25 16:07:39 |
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Basic information
Public title
Long-term physical, cognitive and Quality-of-Life outcome and their risk factors in severe sepsis
Acronym
Long-term outcome and its risk factors in severe sepsis
Scientific Title
Long-term physical, cognitive and Quality-of-Life outcome and their risk factors in severe sepsis
Scientific Title:Acronym
Long-term outcome and its risk factors in severe sepsis
Region
| Japan |
Condition
Condition
Severe sepsis
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify long-term physical, cognitive and Quality-of-Life outcome and their risk factors in severe sepsis in single Emergency Center.
Basic objectives2
Others
Basic objectives -Others
Observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Long-term physical, cognitive function and Quality-of-Life are impaired in severe sepsis after hospital discharge.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are admitted at Tohoku Universtiy Hospital and diagnosed as Severe Sepsis
Key exclusion criteria
Age less than 20 years old
Patients whose families refuse to active treatment
Target sample size
200
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
Emergency Medicine
Zip code
Address
1-1 Seiryo-machi Aoba-ku, Sendai
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisuke Kudo |
Organization
Tohoku University Hospital
Division name
Emergency Center
Zip code
Address
1-1 Seiryo-machi Aoba-ku, Sendai
TEL
022-717-7489
Homepage URL
information@emergency-medicine.med.thoku.ac.jp
Sponsor or person
Institute
Division of Emergency Medicine, Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Donation
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
| 2013 | Year | 09 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | 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
Observation list
Demographics, Cognitive function before admission, Vital signs and laboratory date at admission, Interventions, Vital signs and laboratory date on Day 4, Comorbidity related to severe sepsis. 1, 6,12,and 24 months after admission; Physical function, Main organ function, Cognitive function, QOL, Social condition and circumference, Mental disorder
Observation period: 2 years after admission
Management information
Registered date
| 2013 | Year | 06 | Month | 25 | Day |
Last modified on
| 2013 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012913
