UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029072 |
|---|---|
| Receipt number | 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 | 2019/09/11 16:57:21 |
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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 | Takatsugu Murakoshi |
| Middle name | |
| Last name | Takatsugu Murakoshi |
Organization
Tokyo Metropolitan Children's Medical Center
Division name
Gastroenterology
Zip code
183-8561
Address
2-8-29 Musasidai,Fuchu city 183-8561,Japan
TEL
042-300-5111
takatsugu_muraoshi@tmhp.jp
Public contact
Name of contact person
| 1st name | Takatsugu MUrakoshi |
| Middle name | |
| Last name | Takatsugu Murakoshi |
Organization
Tokyo Metropolitan Children's Medical Center
Division name
Gastroenterology
Zip code
183-8561
Address
2-8-29 Musasidai,Fuchu city 183-8561,Japan
TEL
042-300-5111
Homepage URL
takatsugu_muraoshi@tmhp.jp
Sponsor or person
Institute
Tokyo Metropolitan Children's Medical Center
Institute
Department
Personal name
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
Tokyo Metropolitan Children's Medical Center
Address
2-8-29 Musasidai,Fuchu city 183-8561,Japan
Tel
042-300-5111
sn_rinri@tmhp.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
| 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
| 2017 | Year | 10 | Month | 03 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 11 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 09 | Day |
Last modified on
| 2019 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033250
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