Ethanol Locks for the Treatment of Central Venous Line Infections

NCT00680459 | Terminated Phase 3 Results

• 1 other identifier: IRB08-064
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

central line infection; 70% ethanol; Sepsis

Outcome Measures

Primary Outcomes (1)

• Clearance of Central Venous Line Infection by Day 6 of Study

  6 days

Secondary Outcomes (2)

• Preservation of Central Venous Line (Line Not Requiring Removal) by Day 35 of Study

  35 days

• Recurrence of Central Venous Line Infection Within 35 Days of Enrollment

  35 days

Study Arms (2)

1

EXPERIMENTAL

70% ethanol lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. 70% ethanol solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.

Drug: 70% ethanol

2

PLACEBO COMPARATOR

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. heparin flush solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.

Drug: heparin flush solution

Interventions

70% ethanol DRUG

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.

Also known as: alcohol

1

heparin flush solution DRUG

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.

Also known as: anticoagulant

2

Eligibility Criteria

• Age: 6 Months - 23 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• age 6 months-23 years
• documented central line infection with bacteria or fungus (positive blood culture)

You may not qualify if:

• allergy or intolerance to ethanol
• pregnant or breastfeeding
• central line tunnel or exit site infection

Sponsors & Collaborators

• Baystate Medical Center: lead

Study Sites (1)

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

Related Publications (1)

• Onland W, Shin CE, Fustar S, Rushing T, Wong WY. Ethanol-lock technique for persistent bacteremia of long-term intravascular devices in pediatric patients. Arch Pediatr Adolesc Med. 2006 Oct;160(10):1049-53. doi: 10.1001/archpedi.160.10.1049.

  PMID: 17018464 BACKGROUND

MeSH Terms

Conditions

Sepsis

Interventions

Ethanol; Anticoagulants

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Hematologic Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Results Point of Contact

• Title: Dr. Christine McKiernan
• Organization: Baystate Medical Center

Christine.McKiernan@bhs.org

413-794-5370

Study Officials

• Christine A McKiernan, MD

  Baystate Medical Center

  PRINCIPAL INVESTIGATOR

• Amanda Conti, MD

  Baystate Medical Center

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Chief, Pediatric Critical Care

Study Record Dates

• First Submitted: May 16, 2008
• First Posted: May 20, 2008
• Study Start: May 1, 2008
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: March 12, 2014
• Results First Posted: March 12, 2014

Record last verified: 2014-01

Locations

US (1)