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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016955
Receipt No. 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

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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
Email 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
Email seveneleven711thanks39@msn.com

Sponsor
Institute Chiba University Graduate School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019679

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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