Ethanol Locks for the Treatment of Central Venous Line Infections

Summary

Ethanol Locks as an Adjunct Treatment for Central Venous Line Infections

Purpose To evaluate the effectiveness of a 70% ethanol lock solution when used as an adjunct therapy with antibiotics to treat central venous line infections

Study Design Randomized Controlled Trial

Study Protocol Only those patients meeting all inclusion criteria and no exclusion criteria will be eligible to participate in this study. Once identified, signed informed consent will be obtained from the patient's guardian and the patient himself/herself depending on age. Patients will be randomized into 2 groups: Group 1 - those patients who will receive ethanol lock therapy and Group 2- those patients who will receive placebo therapy in the form of a heparin lock solution.

Outcome Measures Treatment success as defined by-

* Clearance of the infection as documented by negative blood cultures on day 6 (one day after completed of lock treatment)
* Preservation of the line at 30 days post treatment (day 35 of the study), this will be documented by a chart review in CIS and telephone interview to ensure no further growth from blood cultures or infections

Treatment failure as defined by-

* Clinical worsening during treatment
* Removal of the line due to persistent infection or sepsis
* Recurrence of infection with the same pathogen within 30 days

Conditions

• Bloodstream Infection

Interventions

DRUG

70% ethanol

70% ethanol lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. Volume of solution instilled varies from 0.8-1.9ml depending on volume of the lumen and hub of the particular size line being treated. 70% ethanol solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.

DRUG

heparin flush solution

heparin flush (10 units/ml) lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. Volume of solution instilled varies from 0.8-1.9ml depending on volume of the lumen and hub of the particular size line being treated. Heparin lock solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.

Sponsors & Collaborators

• Baystate Medical Center

  lead OTHER

Principal Investigators

• Christine A McKiernan, MD · Baystate Medical Center

• Amanda Conti, MD · Baystate Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

6 Months

Max Age

23 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-05-31

Primary Completion

2011-06-30

Completion

2011-06-30

Countries

• United States

Study Locations