Ethanol Lock for the Salvage of Infected Long-term Vascular Access
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Lock Con Etanolo Per il Salvataggio di Dispositivi Vascolari a Lungo Termine. Un Trial Clinico Multicentrico Controllato Randomizzato|
- Ratio of saved devices [ Time Frame: 7 days ] [ Designated as safety issue: No ]
- Number of participants with adverse events linked to ethanol lock as a measure of safety and tolerability [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]
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.
- Number of patients with proper parenteral therapy [ Time Frame: 7 days ] [ Designated as safety issue: No ]Verified by an Infectious Diseases Specialist
- Ratio of saved devices [ Time Frame: 15-30-60 days ] [ Designated as safety issue: No ]
- Time for next bacteriemic episode [ Time Frame: 30 days after the end of lock ] [ Designated as safety issue: No ]
|Study Start Date:||June 2010|
|Estimated Study Completion Date:||June 2013|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Treatment with a combination of ethanol-lock and parenteral therapy
Drug: Ethanol-lock therapy
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.
Active Comparator: Antibiotic lock
Treatment with a combination of antibiotic-lock and parenteral therapy
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.
|Contact: Michele Pagani, MDfirstname.lastname@example.org|
|Contact: Andrea Bottazzi, MDemail@example.com|
|Fondazione IRCCS Policlinico "San Matteo"||Recruiting|
|Pavia, PV, Italy, 27100|
|Principal Investigator: Michele Pagani, M.D.|
|Sub-Investigator: Andrea Bottazzi, M.D.|
|Principal Investigator:||Michele Pagani, M.D.||Fondazione IRCCS Policlinico "San Matteo" Pavia ITALY|