Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Ethanol Locks for the Treatment of Central Venous Line Infections

Resource links provided by NLM:


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 ]

Enrollment: 13
Study Start Date: May 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: anticoagulant

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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Massachusetts
Baystate Medical Center
Springfield, Massachusetts, United States, 01199
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:
Responsible Party: christine mckiernan, Division Chief, Pediatric Critical Care, Baystate Medical Center
ClinicalTrials.gov Identifier: NCT00680459     History of Changes
Other Study ID Numbers: IRB08-064
Study First Received: May 16, 2008
Results First Received: September 3, 2013
Last Updated: January 29, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Baystate Medical Center:
central line infection
70% ethanol
Sepsis

Additional relevant MeSH terms:
Communicable Diseases
Infection
Anti-Infective Agents
Ethanol
Heparin
Pharmaceutical Solutions
Anti-Infective Agents, Local
Anticoagulants
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 19, 2014