UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013677 |
|---|---|
| Receipt number | R000015969 |
| Scientific Title | Study of Ethanol lock therapy for Central Venous Catheter-Related Bloodstream Infection |
| Date of disclosure of the study information | 2014/04/10 |
| Last modified on | 2017/06/16 09:50:05 |
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Basic information
Public title
Study of Ethanol lock therapy for Central Venous Catheter-Related Bloodstream Infection
Acronym
Study of Ethanol lock therapy for CRBSI
Scientific Title
Study of Ethanol lock therapy for Central Venous Catheter-Related Bloodstream Infection
Scientific Title:Acronym
Study of Ethanol lock therapy for CRBSI
Region
| Japan |
Condition
Condition
catheter related blood stream infection
Classification by specialty
| Infectious disease | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of the effectiveness of ethanol lock for CRBSI
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Improvement of CRBSI
Key secondary outcomes
Safety of ethanol lock
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Ethanol lock
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
| 20 | years-old | > |
Gender
Male and Female
Key inclusion criteria
CRBSI patients removal of the CVC is undesirable.
Patients with fever of unknown origin and cannot be diagnosis of CRBSI.
Key exclusion criteria
Patients have allergy for ethanol.
Patients have severe liver disfunction, total bilirubin 3 mg / dL or more, ascites difficult management, severe bleeding tendency.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kimiyoshi Sakaguchi |
Organization
Hamamatsu University School of Medicine
Division name
Department of Pediatrics
Zip code
Address
1-20-1 Handayama, Higashi-ward, Hamamatsu
TEL
053-435-2312
k-saka@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kimiyoshi Sakaguchi |
Organization
Hamamatsu University School of Medicine
Division name
Department of Pediatrics
Zip code
Address
1-20-1 Handayama, Higashi-ward, Hamamatsu
TEL
053-435-2312
Homepage URL
k-saka@hama-med.ac.jp
Sponsor or person
Institute
Department of Pediatrics, Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Sanofi K.K.
Organization
Division
Category of Funding Organization
Profit organization
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
| 2014 | Year | 04 | Month | 10 | 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
Only one case was registered and there was a deviation from the protocol. We decided that registration of a new case can not be expected in the future and terminated the study.
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
Terminated
Date of protocol fixation
| 2014 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 10 | Day |
Last follow-up date
| 2017 | Year | 05 | Month | 29 | Day |
Date of closure to data entry
| 2017 | Year | 05 | Month | 29 | Day |
Date trial data considered complete
| 2017 | Year | 05 | Month | 29 | Day |
Date analysis concluded
| 2017 | Year | 05 | Month | 29 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 10 | Day |
Last modified on
| 2017 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015969
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
