UMIN-CTR Clinical Trial

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

catheter-related blood stream infection

Classification by specialty

Surgery in general

Child

Classification by malignancy

Others

Genomic information

NO

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

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)

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

The Japanese Society for Metabolism Research in Pediatric Surgery

Institute

Department

Personal name

Organization

The Japanese Society for Metabolism Research in Pediatric Surgery

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2017

Year

12

Month

01

Day

URL releasing protocol

http://www10.showa-u.ac.jp/-psurgery/pedsurg-metabolism/committee.html

Publication of results

Published

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

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 related information

Registered date

2017

Year

11

Month

25

Day

Last modified on

2020

Year

11

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034385