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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036879
Receipt No. 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 2019/05/28

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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 Tatsuo
Middle name
Last name Kuroda
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
Email kuroda@z8.keio.jp

Public contact
Name of contact person
1st name Motohiro
Middle name
Last name Kano
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
Email knmthr@keio.jp

Sponsor
Institute Keio University
Institute
Department

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
Email 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
2019 Year 05 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042025

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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