Ethanol Locks for the Treatment of Central Venous Line Infections

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

Study Overview

• Status: Terminated
• Conditions: Bloodstream Infection
• Intervention / Treatment: Drug: 70% ethanol; Drug: heparin flush solution

Detailed Description

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

1. 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"
2. Cleanse Hands
3. Use aseptic Technique throughout procedure
4. Clean injection cap/posi-flow cap with alcohol for 30 seconds and let dry
5. Unclamp the catheter and gently flush with normal saline to ensure patency of the catheter

6. 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
7. Clamp the catheter
8. Label the locked lumen with the provided label so that med is not flushed through the catheter
9. Let ethanol dwell in catheter continuously for 4 hours
10. When ethanol has dwelled for 4 hours, withdraw and discard the lock solution
11. The above procedure should be repeated daily for 5 consecutive days
12. The above procedure should be repeated to each lumen of the central venous catheter daily if there are multiple lumens

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Springfield, Massachusetts, United States, 01199
      • Baystate Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; 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.; Other Names: alcohol
Placebo Comparator: 2; 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.; Other Names: anticoagulant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Clearance of Central Venous Line Infection by Day 6 of Study	6 days

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Baystate Medical Center
• Investigators: Principal Investigator: Christine A McKiernan, MD, Baystate Medical Center; Study Director: Amanda Conti, MD, Baystate Medical Center

Publications and helpful links

General 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. doi: 10.1001/archpedi.160.10.1049.

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: May 16, 2008
• First Submitted That Met QC Criteria: May 19, 2008
• First Posted (Estimate): May 20, 2008

Study Record Updates

• Last Update Posted (Estimate): March 12, 2014
• Last Update Submitted That Met QC Criteria: January 29, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: Sepsis; central line infection; 70% ethanol
• Additional Relevant MeSH Terms: Pathologic Processes; Systemic Inflammatory Response Syndrome; Inflammation; Disease Attributes; Sepsis; Infections; Communicable Diseases; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Central Nervous System Depressants; Fibrinolytic Agents; Fibrin Modulating Agents; Ethanol; Heparin; Anticoagulants
• Other Study ID Numbers: IRB08-064