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

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

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 Overview

• Status: Unknown
• Conditions: Bacteremia
• Intervention / Treatment: Drug: Ethanol-lock therapy; Drug: Antibiotic-lock

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • PV
    • Pavia, PV, Italy, 27100
      • Recruiting
      • Fondazione IRCCS Policlinico "San Matteo"
      • Principal Investigator: Michele Pagani, M.D.
      • Sub-Investigator: Andrea Bottazzi, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ethanol-lock; 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	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Ratio of saved devices	7 days

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: IRCCS Policlinico S. Matteo
• Investigators: Principal Investigator: Michele Pagani, M.D., Fondazione IRCCS Policlinico San Matteo, Pavia, Italy

Publications and helpful links

General Publications

• 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. Erratum In: Infect Control Hosp Epidemiol. 2010 Feb;31(2):202.

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Anticipated): December 1, 2012
• Study Completion (Anticipated): June 1, 2013

Study Registration Dates

• First Submitted: August 17, 2010
• First Submitted That Met QC Criteria: August 20, 2010
• First Posted (Estimate): August 23, 2010

Study Record Updates

• Last Update Posted (Estimate): January 5, 2012
• Last Update Submitted That Met QC Criteria: January 4, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: sepsis; central venous catheter; vascular access; ethanol; lock therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Bacterial Infections; Bacterial Infections and Mycoses; Sepsis; Bacteremia; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Central Nervous System Depressants; Ethanol; Anti-Bacterial Agents
• Other Study ID Numbers: ETHCVC