Ignite Creation Date:
2025-12-24 @ 2:23 PM
Ignite Modification Date:
2026-02-28 @ 11:54 PM
Study NCT ID:
NCT00680459
Status:
TERMINATED
Last Update Posted:
2014-03-12
First Post:
2008-05-16
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ethanol Locks for the Treatment of Central Venous Line Infections
Sponsor:
Baystate Medical Center
Organization:
Study Overview
Official Title:
Ethanol Locks for the Treatment of Central Venous Line Infections
Status:
TERMINATED
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
inability to enroll adequate number of patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: