Ethanol Locks for the Treatment of Central Venous Line Infections

This study has been terminated.
(inability to enroll adequate number of patients)
Sponsor:
Information provided by (Responsible Party):
christine mckiernan, Baystate Medical Center
ClinicalTrials.gov Identifier:
NCT00680459
First received: May 16, 2008
Last updated: January 29, 2014
Last verified: January 2014

May 16, 2008
January 29, 2014
May 2008
June 2011   (final data collection date for primary outcome measure)
Clearance of Central Venous Line Infection by Day 6 of Study [ Time Frame: 6 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00680459 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Ethanol Locks for the Treatment of Central Venous Line Infections
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

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
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Bloodstream Infection
  • 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 Name: alcohol
  • 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 Name: anticoagulant
  • 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.
    Intervention: Drug: 70% ethanol
  • 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.
    Intervention: Drug: heparin flush solution
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
13
June 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
6 Months to 23 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00680459
IRB08-064
No
christine mckiernan, Baystate Medical Center
Baystate Medical Center
Not Provided
Principal Investigator: Christine A McKiernan, MD Baystate Medical Center
Study Director: Amanda Conti, MD Baystate Medical Center
Baystate Medical Center
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP