Drawing up a guideline for ethanol lock therapy to treat catheter-related blood stream infection in pediatric patients.

Not Applicable

• Conditions: catheter-related blood stream infection

• Registration Number: JPRN-UMIN000030116
• Lead Sponsor: The Japanese Society for Metabolism Research in Pediatric Surgery

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-12-01
• Study Completion: 2018-08-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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)