UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036879 |
|---|---|
| Receipt number | R000042025 |
| Scientific Title | Therapeutic ethanol lock therapy to improve the success rate of treatment in Catheter Related Blood Stream Infections |
| Date of disclosure of the study information | 2019/05/29 |
| Last modified on | 2023/11/30 23:53:12 |
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Basic information
Public title
Therapeutic Ethanol Lock Therapy to improve the success rate of treatment in Catheter Related Blood Stream Infections
Acronym
Keio-ELT2
Scientific Title
Therapeutic ethanol lock therapy to improve the success rate of treatment in Catheter Related Blood Stream Infections
Scientific Title:Acronym
Keio-ELT2
Region
| Japan |
Condition
Condition
Catheter Related Blood Stream Infection; CRBSI
Classification by specialty
| Not applicable | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The principal objective of this trial is to evaluate the overall effectiveness of the ELT on CRBSI. The secondary objective of this trial is to evaluate the effectiveness of the ELT on each bacteria causing CRBSI.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of successful preservation of the CVC catheter after each CRBSI event (success is defined as the affected catheter is safe to use at 4 weeks later to the initiation of the ELT to CRBSI without recurrence of CRBSI)
Key secondary outcomes
Occurrence rate of CRBSI.
Successful rate to achieve of the negative blood culture.
Relativity of each bacteria causing CRBSI and patients's background or success rate of preservation.
Number of times to perform ELT until the catheter required replacement.
Other events related to the catheter such as tunnel infection, complicated infection or breakage.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Perform the catheter lock technic using ethanol for 7days, once a day after the definitive diagnosis of CRBSI was made.
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
Those who meets two conditions listed below are eligible to this trial
1. the patient has an implanted CVC catheter for long term use.
The catheter includes but not limited to
BrovIac Catheter
Hickman Catheter
Silascon catheter
Implanted CV port.
2. Their doctor thinks the patient requires preservation of the catheter when treating the CRBSI.
Key exclusion criteria
Those who meet these conditions are excluded from the trial.
1. the catheter is not made of silicon
2. the patient has allergy to alcohol
3. the patient is pregnant
4. the patient is breastfeeding
5. the patient does not require CVC preservation therapy
6. the patient or the patient guardians do not consent to the trial
7. any patients whose doctor thinks is not eligible.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Akihiro |
| Middle name | |
| Last name | Fujino |
Organization
Keio University
Division name
School of medicine, Department of Pediatric Surgery
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku, Tokyo, Japan
TEL
03-5363-3024
a.fujino@keio.jp
Public contact
Name of contact person
| 1st name | Mototoshi |
| Middle name | |
| Last name | Kato |
Organization
Keio University
Division name
School of medicine, Department of Pediatric Surgery
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku, Tokyo, Japan
TEL
03-5363-3024
Homepage URL
mototoshi77@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Funded by the primary organization
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
Keio University School of Medicine IRB
Address
35 Shinanomachi, Shinjuku, Tokyo, Japan
Tel
03-3353-1211 Ext;62014
med-rinri-jimu@adst.keio.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 | 05 | Month | 29 | 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 | 04 | Month | 04 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 29 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 05 | Month | 28 | Day |
Last modified on
| 2023 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042025
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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