Ethanol Lock for the Salvage of Infected Long-term Vascular Access
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|ClinicalTrials.gov Identifier: NCT01186172|
Recruitment Status : Unknown
Verified January 2012 by Michele Pagani, IRCCS Policlinico S. Matteo.
Recruitment status was: Recruiting
First Posted : August 23, 2010
Last Update Posted : January 5, 2012
|Condition or disease||Intervention/treatment||Phase|
|Bacteremia||Drug: Ethanol-lock therapy Drug: Antibiotic-lock||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Lock Con Etanolo Per il Salvataggio di Dispositivi Vascolari a Lungo Termine. Un Trial Clinico Multicentrico Controllato Randomizzato|
|Study Start Date :||June 2010|
|Estimated Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||June 2013|
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.
- Ratio of saved devices [ Time Frame: 7 days ]
- Number of participants with adverse events linked to ethanol lock as a measure of safety and tolerability [ Time Frame: 60 days ]
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 ]Verified by an Infectious Diseases Specialist
- Ratio of saved devices [ Time Frame: 15-30-60 days ]
- Time for next bacteriemic episode [ Time Frame: 30 days after the end of lock ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01186172
|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|