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

Study Overview
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Brief Summary
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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.

Official Title
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Lock Con Etanolo Per il Salvataggio di Dispositivi Vascolari a Lungo Termine. Un Trial Clinico Multicentrico Controllato Randomizzato

Conditions
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Bacteremia

Intervention / Treatment
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* Drug: Ethanol-lock therapy
* Drug: Antibiotic-lock


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ethanol-lock<br>Treatment with a combination of ethanol-lock and parenteral therapy | Drug: Ethanol-lock therapy<br>* Daily ethanol-lock with 70% ethanol instilled in device dead-space, leaved in place for the longest possible interval, and then discarded. For dialysis devices, it is acceptable to leave the lock in place between dialysis sessions. Lock therapy will be continued for 7 days.<br>|
| Active Comparator: Antibiotic lock<br>Treatment with a combination of antibiotic-lock and parenteral therapy | Drug: Antibiotic-lock<br>* Daily antibiotic-lock according to 2009 IDSA Guidelines,instilled in device dead-space, leaved in place for the longest possible interval, and then discarded. For dialysis devices, it is acceptable to leave the lock in place between dialysis sessions. Lock therapy will be continued for 7 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ratio of saved devices |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events linked to ethanol lock as a measure of safety and tolerability | Major adverse event (stop protocol): anaphylaxis, antabuse-like reaction, device damage, severe dysphoric reaction. Minor adverse events (do not stop protocol): nausea, vomiting, headache, dizziness. | 60 days | 
| Number of patients with proper parenteral therapy | Verified by an Infectious Diseases Specialist | 7 days | 
| Ratio of saved devices |  | 15-30-60 days | 
| Time for next bacteriemic episode |  | 30 days after the end of lock | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ethanol, lock therapy, vascular access, central venous catheter, sepsis