Ethanol Lock for the Salvage of Infected Long-term Vascular Access

Bacteremia Clinical Trial

Official title:

Lock Con Etanolo Per il Salvataggio di Dispositivi Vascolari a Lungo Termine. Un Trial Clinico Multicentrico Controllato Randomizzato

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01186172
• Other study ID #: ETHCVC
• Status: Unknown status
• Phase: Phase 3
• First received: August 17, 2010
• Last updated: January 4, 2012
• Start date: June 2010
• Est. completion date: June 2013

Study information

• Verified date: January 2012
• Source: IRCCS Policlinico S. Matteo
• Contact: Michele Pagani, MD
• Phone: +390382502767
• Email: m.pagani[@]smatteo.pv.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 200
• Est. completion date: June 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year and older

Eligibility

Inclusion Criteria:

• Age: >1 year and 10 Kgs

• Long-term vascular device in place at least for 7 days

• Catheter-related infection (at least presumed)

• Will to save the infected device (expected high risk access)

Exclusion Criteria:

• Known ethanol-allergy

• Known antabuse-like drugs in use

• Religious refusal

• S.aureus or Candida spp. as main pathogens (except in the unusual and documented scenarios when replacement of vascular access device proved to be very difficult)

• Tract or pocket infection

• Complicated infection (septic shock, infectious thrombosis, osteomyelitis, endocarditis)

Related Conditions & MeSH terms

• Bacteremia

Intervention

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.
• Antibiotic-lock
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.

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Policlinico "San Matteo"	Pavia	PV

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Policlinico S. Matteo

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. Review. Erratum in: Infect Control Hosp Epidemiol. 2010 Feb;31(2):202. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ratio of saved devices		7 days
Secondary	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
Secondary	Number of patients with proper parenteral therapy	Verified by an Infectious Diseases Specialist	7 days
Secondary	Ratio of saved devices		15-30-60 days
Secondary	Time for next bacteriemic episode		30 days after the end of lock