UMIN-CTR Clinical Trial

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
Last 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
Email	kuroda-t@keio.jp

Public contact
1st 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
Email	kiyotomo@keio.jp

Sponsor
Institute	Keio university hospital
Institute
Department

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
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

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032698