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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2013-06-30

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.

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Detailed Description

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Conditions

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Bacteremia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Ethanol-lock

Treatment with a combination of ethanol-lock and parenteral therapy

Group Type EXPERIMENTAL

Ethanol-lock therapy

Intervention Type DRUG

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.

Antibiotic lock

Treatment with a combination of antibiotic-lock and parenteral therapy

Group Type ACTIVE_COMPARATOR

Antibiotic-lock

Intervention Type DRUG

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.

Interventions

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Ethanol-lock therapy

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.

Intervention Type DRUG

Antibiotic-lock

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.

Intervention Type DRUG

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)

Minimum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No