Ethanol Lock for the Salvage of Infected Long-term Vascular Access

• Status: Unknown status
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Long-term venous devices (e.g.Ports, tunneled catheters,...) may become infected. Sometimes it is very difficult to treat the infection and it is necessary to remove the device. The purpose of this study is to determine the efficacy of instilled ethanol ("ethanol lock therapy") versus instilled antibiotics ("antibiotic lock therapy") to save long-term venous device when infected, preventing their removal.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IRCCS Policlinico S. Matteo
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Ethanol

Criteria

Inclusion Criteria:

• Age: >1 year and 10 Kgs

• Long-term vascular device in place at least for 7 days

• Catheter-related infection (at least presumed)

• Will to save the infected device (expected high risk access)

Exclusion Criteria:

• Known ethanol-allergy

• Known antabuse-like drugs in use

• Religious refusal

• S.aureus or Candida spp. as main pathogens (except in the unusual and documented scenarios when replacement of vascular access device proved to be very difficult)

• Tract or pocket infection

• Complicated infection (septic shock, infectious thrombosis, osteomyelitis, endocarditis)