UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016955 |
|---|---|
| Receipt number | R000019679 |
| Scientific Title | Significance of therapeutic drug monitoring during enteral administration of vancomycin in critically ill patients: a retrospective observational study |
| Date of disclosure of the study information | 2015/03/30 |
| Last modified on | 2015/03/28 00:11:17 |
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Basic information
Public title
Significance of therapeutic drug monitoring during enteral administration of vancomycin in critically ill patients: a retrospective observational study
Acronym
Therapeutic drug monitoring during enteral vancomycin administration
Scientific Title
Significance of therapeutic drug monitoring during enteral administration of vancomycin in critically ill patients: a retrospective observational study
Scientific Title:Acronym
Therapeutic drug monitoring during enteral vancomycin administration
Region
| Japan |
Condition
Condition
Clostridium difficile enteritis and methicillin resistant Staphylococcus aureus enteritis
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify risk factors related to elevation of serum VCM concentration during enteral VCM administration
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
renal dysfunction
renal replacement therapy
gastrointestinal symptoms (amount of diarrhea or melena)
Key secondary outcomes
The length of the ICU stay and ICU mortality
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
selected patients who were admitted to the medical surgical ICU (22 beds) of Chiba University Hospital (Chiba, Japan) between December 2006 and January 2014, who were administered oral or enteral VCM, and in whom serum VCM concentrations were measured
Key exclusion criteria
Pediatric patients under the age of 18 and patients concomitantly administered parenteral VCM
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takehiko Oami |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Emergency and Critical Care Medicine
Zip code
Address
1-8-1 Inohana, Chuo, Chiba, Chiba
TEL
043-222-7171
seveneleven711thanks39@msn.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takehiko Oami |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Emergency and Critical Care Medicine
Zip code
Address
1-8-1 Inohana, Chuo, Chiba, Chiba
TEL
043-222-7171
Homepage URL
seveneleven711thanks39@msn.com
Sponsor or person
Institute
Chiba University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Chiba University Graduate School of Medicine
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
千葉大学医学部付属病院（千葉）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 03 | Month | 30 | 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
| 2014 | Year | 03 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 06 | Day |
Last follow-up date
| 2014 | Year | 10 | Month | 06 | Day |
Date of closure to data entry
| 2014 | Year | 11 | Month | 06 | Day |
Date trial data considered complete
| 2014 | Year | 12 | Month | 06 | Day |
Date analysis concluded
| 2015 | Year | 01 | Month | 06 | Day |
Other
Other related information
a retrospective observational study
Management information
Registered date
| 2015 | Year | 03 | Month | 28 | Day |
Last modified on
| 2015 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019679
