UMIN-CTR Clinical Trial

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 Akira Middle name Last name Toki
Organization	Showa University Hospital
Division name	Division of Pediatric Surgery, Department of Surgery
Zip code	142-8666
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 Sachiko Middle name Last name Miyagawa
Organization	Showa University Hospital
Division name	Division of Pediatric Surgery, Department of Surgery
Zip code	142-8666
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	institutional review board of showa University Hospital
Address	1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8666, Japan
Tel	03-3784-8000
Email	ctsc.admin@ofc.showa-u.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	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	Published

Result
URL related to results and publications	https://onlinelibrary.wiley.com/doi/full/10.1111/ped.14096
Number of participants that the trial has enrolled	49
Results	49 cases from six hospitals were enrolled in the study. Catheter blockage was seen in one case and the CVC was removed. A single course of ELT was effective in episodes 88% (42/48). In the remaining three episodes that failed after a single course of ELT, a second ELT was performed; however, all were ineffective. In episodes 93% (40/42), no CRBSI relapse was seen up to 4 weeks after the end of treatment. In episodes 84% (41/49), the catheter could be preserved for 4 weeks or more after the end of treatment.
Results date posted	2020 Year 11 Month 27 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	We performed a prospective multicenter study in 20 Japanese hospitals September 2014 to August 2018. The study was approved by the Institutional Ethic Review Boards of the participating hospitals. Written informed consent from patient's parents was obtained. If the patient was in elementary school or above, we obtained ascent from them. Inclusion criteria were patients aged over 1 year with long-term indwelling silicone CVC and suspected CRBSI.
Participant flow	Participants received lock therapy with ethanol (70% ethanol in water) and all patients were treated with the same regimen. All participants also received appropriate systemic antibiotic therapy at the discretion of the treating physician for 7 days or until inflammatory findings were relieved. After 7 days of continuous treatment, if the blood culture was negative and clinical symptoms and examination data were improved, the first course of the ELT was finished and CVC was started again. If the blood culture was positive or clinical symptoms or examination data did not improve, we considered whether to start the second course of the ELT or to remove the CVC. If the therapy was ineffective after three courses, we considered that removal of the CVC was indicated. Doctors registered in the trials performed lock treatment during inpatient stays. ELT was discontinued in the event of CVC removal, serious adverse events, such as liver dysfunction or catheter occlusion, and patient or clinician's request.
Adverse events	Catheter blockage was seen in 1 case and CVC was removed. Flushing of the face was seen in 2 episodes as an adverse event; however, these were transient and soon disappeared.
Outcome measures	Effective rate of ELT for single and multiple times, presence or absence of relapse of CRBSI within 4 weeks and whether catheter could be salvaged for 4 weeks were examined. Emergent abnormal liver function was defined as the development of an increase in alanine aminotransferase, aspartic aminotransferase, alkaline phosphatase and bilirubin assays by at least two times that reached at least twice the upper normal limit for the patient's age and sex. As symptoms associated with ethanol injection, the presence or absence of clinical symptoms such as skin flushing, sickness or nausea was confirmed.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 09 Month 01 Day
Date of IRB	2015 Year 09 Month 14 Day
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	2020 Year 11 Month 27 Day

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