Ethanol Locks for the Treatment of Central Venous Line Infections

Bloodstream Infection Clinical Trial

Official title:

Ethanol Locks for the Treatment of Central Venous Line Infections

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00680459
• Other study ID #: IRB08-064
• Status: Terminated
• Phase: Phase 3
• First received: May 16, 2008
• Last updated: January 29, 2014
• Start date: May 2008
• Est. completion date: June 2011

Study information

• Verified date: January 2014
• Source: Baystate Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 23 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bloodstream Infection
• Communicable Diseases
• Infection

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Baystate Medical Center	Springfield	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Baystate Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clearance of Central Venous Line Infection by Day 6 of Study		6 days	No
Secondary	Preservation of Central Venous Line (Line Not Requiring Removal) by Day 35 of Study		35 days	No
Secondary	Recurrence of Central Venous Line Infection Within 35 Days of Enrollment		35 days	No