Bloodstream Infection
Conditions
Keywords
central line infection, 70% ethanol, Sepsis
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
Interventions
DRUG70% 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.
DRUGheparin 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.
Sponsors
Baystate Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
6 Months to 23 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clearance of Central Venous Line Infection by Day 6 of Study | 6 days |
Secondary
| Measure | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 70% Ethanol Solution 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. | 7 |
| Heparin Flush 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. | 6 |
| Total | 13 |
Baseline characteristics
| Characteristic | Heparin Flush | 70% Ethanol Solution | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 6 Participants | 7 Participants | 13 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 6.33 years STANDARD_DEVIATION 4 | 7.4 years STANDARD_DEVIATION 4.96 | 6.9 years STANDARD_DEVIATION 4.4 |
| Region of Enrollment United States | 6 participants | 7 participants | 13 participants |
| Sex: Female, Male Female | 2 Participants | 3 Participants | 5 Participants |
| Sex: Female, Male Male | 4 Participants | 4 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 7 | 0 / 6 |
| serious Total, serious adverse events | 0 / 7 | 0 / 6 |
Outcome results
Primary
Clearance of Central Venous Line Infection by Day 6 of Study
Time frame: 6 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 70% Ethanol Solution | Clearance of Central Venous Line Infection by Day 6 of Study | 7 number of CVL cleared |
| Heparin Flush | Clearance of Central Venous Line Infection by Day 6 of Study | 6 number of CVL cleared |
Secondary
Preservation of Central Venous Line (Line Not Requiring Removal) by Day 35 of Study
Time frame: 35 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 70% Ethanol Solution | Preservation of Central Venous Line (Line Not Requiring Removal) by Day 35 of Study | 6 number of lines preserved |
| Heparin Flush | Preservation of Central Venous Line (Line Not Requiring Removal) by Day 35 of Study | 6 number of lines preserved |
Secondary
Recurrence of Central Venous Line Infection Within 35 Days of Enrollment
Time frame: 35 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 70% Ethanol Solution | Recurrence of Central Venous Line Infection Within 35 Days of Enrollment | 3 # of pts with recurrent infection |
| Heparin Flush | Recurrence of Central Venous Line Infection Within 35 Days of Enrollment | 1 # of pts with recurrent infection |