UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036261 |
|---|---|
| Receipt number | R000041303 |
| Scientific Title | Patients in Advanced Critical Care Center |
| Date of disclosure of the study information | 2019/03/19 |
| Last modified on | 2019/03/19 20:29:19 |
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Basic information
Public title
Patients in Advanced Critical Care Center
Acronym
Patients in Advanced Critical Care Center
Scientific Title
Patients in Advanced Critical Care Center
Scientific Title:Acronym
Patients in Advanced Critical Care Center
Region
| Japan |
Condition
Condition
Severe Infectious Disease
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the relation between endothelial glycocalyx injury and the serum concentration of antibiotics.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The correlation between endothelial glycocalyx injury and the serum concentration of antibiotics.
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
| 18 | years-old | <= |
Age-upper limit
| 99 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patients who enter the Advanced Critical Care Center of Gifu University Hospital
Key exclusion criteria
The patients who refuse the trial.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shinji |
| Middle name | |
| Last name | Ogura |
Organization
Gifu University Hospital
Division name
Advanced Critical Care Center
Zip code
501-1194
Address
1-1 Yanagido, Gifu
TEL
058-230-6448
edm2@gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | Hideshi |
| Middle name | |
| Last name | Okada |
Organization
Gifu University Hospital
Division name
Advanced Critical Care Center
Zip code
501-1194
Address
1-1 Yanagido, Gifu
TEL
058-230-6448
Homepage URL
edm2@gifu-u.ac.jp
Sponsor or person
Institute
Gifu University Hospital
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
Gifu University
Address
1-1 Yanagido Gifu
Tel
058-230-6059
rinri@gifu-u.ac.jp
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
| 2019 | Year | 03 | Month | 19 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 01 | Month | 09 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 09 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 19 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2019 | Year | 03 | Month | 19 | Day |
Last modified on
| 2019 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041303
