UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028571 |
|---|---|
| Receipt number | R000032698 |
| Scientific Title | Ethanol lock therapy for catheter related blood stream infection in pediatric patients with a tunneled catheter or a vascular access port |
| Date of disclosure of the study information | 2017/08/15 |
| Last modified on | 2019/05/28 20:40:43 |
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Basic information
Public title
Ethanol lock therapy for catheter related blood stream infection in pediatric patients with a tunneled catheter or a vascular access port
Acronym
Ethanol lock therapy for catheter related blood stream infection
Scientific Title
Ethanol lock therapy for catheter related blood stream infection in pediatric patients with a tunneled catheter or a vascular access port
Scientific Title:Acronym
Ethanol lock therapy for catheter related blood stream infection
Region
| Japan |
Condition
Condition
Catheter related blood stream infection in patients with a tunnelled catheter
Classification by specialty
| Gastrointestinal surgery | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the safety and efficacy of ethanol rock therapy for catheter related blood stream infection
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. The salvage rate of the catheter
2. The response rate (the rate of negative blood culture obtained on day 5)
3. The rate of recurrent fever which is supposed to be due to catheter related blood stream infection
4. The recurrent rate of CRBSI within 4weeks after the ethanol rock therapy
5. adverse event
Key secondary outcomes
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
| Maneuver |
Interventions/Control_1
Ethanol rock therapy
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with a tunneled catheter(silicone)
or a port fulfilling below requirements
A
1. Diagnosed as a CRBSI by positive blood culture obtained through the catheter along with negative blood culture via peripheral blood
2. No other source of infection
B
The sample obtained through the catheter becomes positive in blood culture 2 hours < faster than the one obtained from peripheral blood.
Informed consent must be obtained.
Key exclusion criteria
1. patients with a non-silicone catheter
2. allergic to ethanol
3. any other conditions that doctors in charge think inappropriate for the treatment
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuo Kuroda |
Organization
Keio University Hospital
Division name
Department of Pediatric Surgery
Zip code
Address
35 Shinanomachi SHinjuku-ku Tokyo
TEL
03-3353-1211
kuroda-t@keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kiyotomo Abe |
Organization
Keio University Hospital
Division name
Department of Pediatric Surgery
Zip code
Address
35 Shinanomachi Shinjuku-ku Tokyo
TEL
03-3353-1211
Homepage URL
kiyotomo@keio.jp
Sponsor or person
Institute
Keio university hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
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
| 2017 | Year | 08 | Month | 15 | 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
| 2017 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 08 | Day |
Last modified on
| 2019 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032698
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
