Ethanol Locks for the Treatment of Central Venous Line Infections - Full Text View

Sponsored by:	Baystate Medical Center
Information provided by:	Baystate Medical Center
ClinicalTrials.gov Identifier:	NCT00680459

Purpose

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

Condition	Intervention	Phase
Bloodstream Infection	Drug: 70% ethanol Drug: heparin flush solution	Phase III

MedlinePlus related topics: Blood Thinners Sepsis

Drug Information available for: Heparin Ethanol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Ethanol Locks for the Treatment of Central Venous Line Infections

Further study details as provided by Baystate Medical Center:

Primary Outcome Measures:

clearance of central venous line infection by day 6 of study [ Time Frame: 6 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

preservation of central venous line (line not requiring removal) by day 35 of study [ Time Frame: 35 days ] [ Designated as safety issue: No ]
recurrence of central venous line infection within 35 days of enrollment [ Time Frame: 35 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	82
Study Start Date:	May 2008
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 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.
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 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.

Arms

Assigned Interventions

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

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.

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

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.

Detailed Description:

Ethanol Lock Technique Protocol (adapted from the Children's Hospital Los Angeles)

Obtain a 3ml syringe made by the Baystate Pharmacy which will contain either sterile 70% ethanol solution or 10 units/ml heparin flush solution. Randomization into study groups will be performed by the pharmacy in patient blocks of 10. Treating physician and nurses will be blinded to patient group assignment. Syringes will be labeled "70% ethanol/heparin lock Study Solution"
Cleanse Hands
Use aseptic Technique throughout procedure
Clean injection cap/posi-flow cap with alcohol for 30 seconds and let dry
Unclamp the catheter and gently flush with normal saline to ensure patency of the catheter
Instill ethanol/heparin lock into the catheter to fill volume
- Broviac Single Lumen 4.2 Fr (ID 0.7) Dose 0.8ml
- Broviac Single Lumen 6.6 Fr (ID 1mm) Dose 0.8ml
- Med-comp Single Lumen Catheter Dose 1.2ml
- Hickman Double Lumen 7 Fr Distal (ID 1mm) Dose 1.2ml
- Hickman Double Lumen 9 Fr Proximal (ID 0.7) Dose 1.2ml
- Med-comp Double Lumen 8 or 10 Fr Dose 1.2ml
- Port-a-cath- Any Port (including priming tubing) Dose 1.9ml
Clamp the catheter
Label the locked lumen with the provided label so that med is not flushed through the catheter
Let ethanol dwell in catheter continuously for 4 hours
When ethanol has dwelled for 4 hours, withdraw and discard the lock solution
The above procedure should be repeated daily for 5 consecutive days
The above procedure should be repeated to each lumen of the central venous catheter daily if there are multiple lumens

Eligibility

Ages Eligible for Study:	6 Months to 23 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00680459

Contacts

Contact: Christine A McKiernan, MD	413-794-4441	christine.mckiernan@bhs.org
Contact: Amanda Conti, MD	413-794-0000	amanda.conti@bhs.org

Locations

United States, Massachusetts
Baystate Medical Center	Recruiting
Springfield, Massachusetts, United States, 01199
Contact: Christine A McKiernan, MD 413-794-4441 christine.mckiernan@bhs.org
Contact: Amanda Conti, MD 413-794-0000 amanda.conti@bhs.org
Principal Investigator: Christine A McKiernan, MD

Sponsors and Collaborators

Baystate Medical Center

Investigators

Principal Investigator:	Christine A McKiernan, MD	Baystate Medical Center
Study Director:	Amanda Conti, MD	Baystate Medical Center

More Information

Publications:

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.

Responsible Party:	Baystate Medical Center ( Christine McKiernan, MD, Principal Investigator )
Study ID Numbers:	IRB08-064
Study First Received:	May 16, 2008
Last Updated:	May 19, 2008
ClinicalTrials.gov Identifier:	NCT00680459
Health Authority:	United States: Institutional Review Board

Keywords provided by Baystate Medical Center:

central line infection
70% ethanol
Sepsis

Study placed in the following topic categories:

Sepsis
Heparin
Calcium heparin
Ethanol

Additional relevant MeSH terms:

Communicable Diseases
Anti-Infective Agents
Anticoagulants
Molecular Mechanisms of Pharmacological Action
Hematologic Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Fibrinolytic Agents

Cardiovascular Agents
Infection
Pharmacologic Actions
Anti-Infective Agents, Local
Fibrin Modulating Agents
Therapeutic Uses
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009