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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030116
Receipt No. R000034385
Scientific Title Drawing up a guideline for ethanol lock therapy to treat catheter-related blood stream infection in pediatric patients.
Date of disclosure of the study information 2017/12/01
Last modified on 2018/11/26

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Basic information
Public title Drawing up a guideline for ethanol lock therapy to treat catheter-related blood stream infection in pediatric patients.
Acronym Drawing up a guideline for ethanol lock therapy to treat catheter-related blood stream infection in pediatric patients.
Scientific Title Drawing up a guideline for ethanol lock therapy to treat catheter-related blood stream infection in pediatric patients.
Scientific Title:Acronym Drawing up a guideline for ethanol lock therapy to treat catheter-related blood stream infection in pediatric patients.
Region
Japan

Condition
Condition catheter-related blood stream infection
Classification by specialty
Surgery in general Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We conduct multicenter prospective research on the CVC-ELT protocol, which is considered to be effective from literature reports etc., to clarify the safety and effectiveness against CRBSI.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1) Short term assessment of efficacy
The definition of successful CVC-ELT required negative blood culture from the lumen of the CVC at day 5 with improvement of blood biochemical examination, disappearance of clinical symptoms such as fever, and no CRBSI relapse within 4 weeks.
2) Evaluation on long-term preservation of CVC
Evaluate whether catheter preservation was possible for 4 weeks or more.
Key secondary outcomes Evaluation of safety
a) Presence or absence of skin flushing, drunkenness, nausea etc. during the treatment period
b) Presence or absence of liver and kidney dysfunction (BUN, Cr, AST, ALT on day 2.5)

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
Interventions/Control_1 1) After flush the contents of the catheter with physiological saline, slowly inject 0.1 to 0.7 mL of 70% ethanol into the catheter and lock it for 2 to 4 hours.
2) After locking, firstly aspirate discarded 70% ethanol charge and flush with normal saline.
3) CVC-ELT implementation is one course in 7 days. Blood cultures are performed from CVC on day 5 after the start of CVC-ELT. Continue CVC-ELT for 2 more days. After 2 days of continuation, if blood culture is negative and clinical symptoms and examination data are improved, the 1st course of CVC - ELT is finished. Even during the 2-day continuation period, if blood culture is positive or clinical symptoms or examination data do not improve, consider whether to start the second course of CVC-ELT or remove CVC. Continue up to 3 courses. If it is invalid, consider removal of CVC.
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
1 years-old <=
Age-upper limit
15 years-old >=
Gender Male and Female
Key inclusion criteria 1) Long-term indwelling silicone CVC (Cook, Broviac or Hickman catheter) is placed.
2) Diagnosed as CRBSI.
3) There is consent from the family.
4) Obtained consent from the clinical trial judging committee.
Key exclusion criteria 1) Patients with ethanol allergy
2) Pregnant women, breast milk supplier
3) Patients with hypercoagulability or easy coagulability
4) Patients who can not reverse blood from CVC
5) Patients who can not use ethanol socially, religiously or culturally
6) Patients whose CVC has been detained in another hospital, fewer information including catheter materials, and this method is judged to be maladaptive
7) Patients who have placed PICC or port type CVC
8) Patients who have placed double-lumen CVC and can not lock both lumens at the same time
9) Patients who doctor concluded that it is inappropriate to participate in this study
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Toki, Tatuzo Hebiguchi
Organization Showa University Hospital
Division name Division of Pediatric Surgery, Department of Surgery
Zip code
Address 1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8666, Japan
TEL 03-3784-8000
Email atoki@med.showa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sachiko Miyagawa
Organization Showa University Hospital
Division name Division of Pediatric Surgery, Department of Surgery
Zip code
Address 1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8666, Japan
TEL 03-3784-8000
Homepage URL http://www10.showa-u.ac.jp/~psurgery/pedsurg-metabolism/committee.html
Email jsmrps@med.showa-u.ac.jp

Sponsor
Institute The Japanese Society for Metabolism Research in Pediatric Surgery
Institute
Department

Funding Source
Organization The Japanese Society for Metabolism Research in Pediatric Surgery
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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 昭和大学病院(東京都)、慶応義塾大学病院(東京都)、大阪大学医学部附属病院(大阪府)、大阪府立母子保健総合医療センター(大阪府)、山梨県立中央病院(山梨県)、さいたま市立病院(埼玉県)、静岡県立こども病院(静岡県)、鹿児島大学病院(鹿児島県)、湘南藤沢徳洲会病院(神奈川県)、佐世保市立総合病院(長崎県)、近畿大学医学部奈良病院(奈良県)、秋田大学医学部附属病院(秋田県)、岡山大学病院(岡山県)

Other administrative information
Date of disclosure of the study information
2017 Year 12 Month 01 Day

Related information
URL releasing protocol http://www10.showa-u.ac.jp/-psurgery/pedsurg-metabolism/committee.html
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
2015 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 09 Month 01 Day
Last follow-up date
2018 Year 08 Month 31 Day
Date of closure to data entry
2018 Year 09 Month 14 Day
Date trial data considered complete
2018 Year 09 Month 30 Day
Date analysis concluded
2018 Year 12 Month 30 Day

Other
Other related information

Management information
Registered date
2017 Year 11 Month 25 Day
Last modified on
2018 Year 11 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034385

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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