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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029072
Receipt No. R000033250
Scientific Title Prospective Intevention Study of Propylactive and Therapeutic Ethanol-Lock Therapy for the Prevention of Catneter-Related Blood Stream Infection in Pediatric Patients with Home Parenteral Nutrition due to Intestinal Failure
Date of disclosure of the study information 2017/09/19
Last modified on 2017/09/09

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Basic information
Public title Prospective Intevention Study of Propylactive and Therapeutic Ethanol-Lock Therapy for the Prevention of Catneter-Related Blood Stream Infection in Pediatric Patients with Home Parenteral Nutrition due to Intestinal Failure
Acronym Ethanol-Lock Therapy(ELT) for the Prevention of Catneter-Related Blood Stream Infection(CRBSI) in Pediatric Patients with Home Parenteral Nutrition(HPN) due to Intestinal Failure
Scientific Title Prospective Intevention Study of Propylactive and Therapeutic Ethanol-Lock Therapy for the Prevention of Catneter-Related Blood Stream Infection in Pediatric Patients with Home Parenteral Nutrition due to Intestinal Failure
Scientific Title:Acronym Ethanol-Lock Therapy(ELT) for the Prevention of Catneter-Related Blood Stream Infection(CRBSI) in Pediatric Patients with Home Parenteral Nutrition(HPN) due to Intestinal Failure
Region
Japan

Condition
Condition Pediatric Patients with Home Parenteral Nutrition due to Intestinal Failure
Classification by specialty
Gastroenterology Infectious disease Hepato-biliary-pancreatic surgery
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Investigation of usefullness and safety for prophylactive(P-ELT) and therapeutic ethanol-lock therapy(T-ELT) for catheter-related blood stream infection rates and catheter replacement rates in pediatric patients with home parenteral nutrition due to intastinal failure
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes CRBSI frequency/1000 catheter days : Convert individual CRBSI times to HPN management days into 1000 HPN management days
Key secondary outcomes 1) Number of T-ELT failure/1000 caheter days
2) Number of catheter occlusion and breakage/1000 catheter days
3) Complications and side effects associated with ELT
4) Pathogenetic organisms and sensitivity for antibacterial agents
5) Number of catheter occulusion and breakage and its mechanical problems
6) Succeaa ratio of T-ELT: number of succeaa T-ELT/ number of T-ELT applications
7) Duration between last P-ELT and CRBSI


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 Device,equipment Maneuver
Interventions/Control_1 single arm
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
29 days-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients with home parenteral nutrition inerting central venous catheter
2) Over 29 days old
3) Patients inserting tunneled silicon catheter(Cook,Broviac and Hickman)
4) Patients obtained cinsent by document from parents(patients over 20 years old)in this study
# Regardless of the underlying medical diseases
Key exclusion criteria 1) Allergy or reaction to ethanol
2) Active infection of catheter inserting portion (including subcutaneous tunnel infection)
3) To be impossible of blood backflow from catheter
4) Patients restricted ethanol by social,religious or cultural reasons
5) Other patients ineligible for this study by doctor's judgment
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takatsugu Murakoshi
Organization Tokyo Metropolitan Children's Medical Center
Division name Gastroenterology
Zip code
Address 2-8-29 Musasidai,Fuchu city 183-8561,Japan
TEL 042-300-5111
Email takatsugu_muraoshi@tmhp.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takatsugu Murakoshi
Organization Tokyo Metropolitan Children's Medical Center
Division name Gastroenterology
Zip code
Address 2-8-29 Musasidai,Fuchu city 183-8561,Japan
TEL 042-300-5111
Homepage URL
Email takatsugu_muraoshi@tmhp.jp

Sponsor
Institute Tokyo Metropolitan Children's Medical Center
Institute
Department

Funding Source
Organization None
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 09 Month 19 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 Preinitiation
Date of protocol fixation
2017 Year 08 Month 29 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 09 Month 09 Day
Last modified on
2017 Year 09 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033250

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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