Ethanol Locks for the Treatment of Central Venous Line Infections

Study Overview
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Brief Summary
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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
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Ethanol Lock Technique Protocol (adapted from the Children's Hospital Los Angeles) 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 Cleanse Hands Use aseptic Technique throughout procedure Clean injection cap/posi-flow cap with alcohol for 30 seconds and let dry Unclamp the catheter and gently flush with normal saline to ensure patency of the catheter 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 Clamp the catheter Label the locked lumen with the provided label so that med is not flushed through the catheter Let ethanol dwell in catheter continuously for 4 hours When ethanol has dwelled for 4 hours, withdraw and discard the lock solution The above procedure should be repeated daily for 5 consecutive days The above procedure should be repeated to each lumen of the central venous catheter daily if there are multiple lumens

Official Title
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Ethanol Locks for the Treatment of Central Venous Line Infections

Conditions
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Bloodstream Infection

Intervention / Treatment
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* Drug: 70% ethanol
* Drug: heparin flush solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 23 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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<br>* 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.<br>* Other names: alcohol;|
| Placebo Comparator: 2<br>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<br>* 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.<br>* Other names: anticoagulant;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clearance of Central Venous Line Infection by Day 6 of Study |  | 6 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preservation of Central Venous Line (Line Not Requiring Removal) by Day 35 of Study |  | 35 days | 
| Recurrence of Central Venous Line Infection Within 35 Days of Enrollment |  | 35 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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central line infection, 70% ethanol, Sepsis