Ethanol Locks for the Treatment of Central Venous Line Infections

Baystate Medical Center

Status and phase: Terminated; Phase 3

Conditions: Bloodstream Infection

Treatments: Drug: heparin flush solution; Drug: 70% ethanol

Study type: Interventional

Funder types: Other

Identifiers

NCT00680459

IRB08-064

Details and patient eligibility

About

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

Full 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

Enrollment: 13 patients

Sex: All

Ages: 6 months to 23 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

13 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

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.

Treatment:

Drug: 70% ethanol

2

Placebo Comparator group

Description:

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.

Treatment:

Drug: heparin flush solution