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Long-term venous devices (e.g.Ports, tunneled catheters,...) may become infected. Sometimes it is very difficult to treat the infection and it is necessary to remove the device. The purpose of this study is to determine the efficacy of instilled ethanol ("ethanol lock therapy") versus instilled antibiotics ("antibiotic lock therapy") to save long-term venous device when infected, preventing their removal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ethanol-lock | Experimental | Treatment with a combination of ethanol-lock and parenteral therapy |
|
| Antibiotic lock | Active Comparator | Treatment with a combination of antibiotic-lock and parenteral therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ethanol-lock therapy | Drug | Daily ethanol-lock with 70% ethanol instilled in device dead-space, leaved in place for the longest possible interval, and then discarded. For dialysis devices, it is acceptable to leave the lock in place between dialysis sessions. Lock therapy will be continued for 7 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Ratio of saved devices | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events linked to ethanol lock as a measure of safety and tolerability | Major adverse event (stop protocol): anaphylaxis, antabuse-like reaction, device damage, severe dysphoric reaction. Minor adverse events (do not stop protocol): nausea, vomiting, headache, dizziness. | 60 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michele Pagani, MD | Contact | +390382502767 | m.pagani@smatteo.pv.it | |
| Andrea Bottazzi, MD | Contact | +390382502767 | a.bottazzi@smatteo.pv.it |
| Name | Affiliation | Role |
|---|---|---|
| Michele Pagani, M.D. | Fondazione IRCCS Policlinico San Matteo, Pavia, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione IRCCS Policlinico "San Matteo" | Recruiting | Pavia | PV | 27100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19803767 | Background | Maiefski M, Rupp ME, Hermsen ED. Ethanol lock technique: review of the literature. Infect Control Hosp Epidemiol. 2009 Nov;30(11):1096-108. doi: 10.1086/606162. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 22, 2015 | |
| Reset | Nov 25, 2015 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 22, 2015 | Nov 25, 2015 |
| ID | Term |
|---|---|
| D016470 | Bacteremia |
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
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|
| Antibiotic-lock | Drug | Daily antibiotic-lock according to 2009 IDSA Guidelines,instilled in device dead-space, leaved in place for the longest possible interval, and then discarded. For dialysis devices, it is acceptable to leave the lock in place between dialysis sessions. Lock therapy will be continued for 7 days. |
|
| Number of patients with proper parenteral therapy |
Verified by an Infectious Diseases Specialist |
| 7 days |
| Ratio of saved devices | 15-30-60 days |
| Time for next bacteriemic episode | 30 days after the end of lock |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |