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

IRCCS Policlinico S. Matteo

Status and phase: Unknown; Phase 3

Conditions: Bacteremia

Treatments: Drug: Antibiotic-lock; Drug: Ethanol-lock therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01186172

ETHCVC

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 1+ year old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Ethanol-lock

Experimental group

Description:

Treatment with a combination of ethanol-lock and parenteral therapy

Treatment:

Drug: Ethanol-lock therapy

Antibiotic lock

Active Comparator group

Description:

Treatment with a combination of antibiotic-lock and parenteral therapy

Treatment:

Drug: Antibiotic-lock