Clinical trial NCT00680459: Ethanol Locks for the Treatment of Central Venous Line Infections
Official title: Ethanol Locks for the Treatment of Central Venous Line Infections
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Bloodstream Infection
Keywords: central line infection
70% ethanol
Sepsis
Lead sponsor: Baystate Medical Center
Sponsor class: OTHER
First posted: 2008-05-20
Enrollment: 13
Sex: ALL
Minimum age (years): 6
Maximum age (years): 23
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: Clearance of Central Venous Line Infection by Day 6 of Study
timeFrame: 6 days
Secondary outcomes:
measure: Preservation of Central Venous Line (Line Not Requiring Removal) by Day 35 of Study
timeFrame: 35 days
measure: Recurrence of Central Venous Line Infection Within 35 Days of Enrollment
timeFrame: 35 days
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
Study officials:
affiliation: Baystate Medical Center
name: Christine A McKiernan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Baystate Medical Center
name: Amanda Conti, MD
role: STUDY_DIRECTOR
References:
citation: 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.