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

This study is currently recruiting participants.
Verified January 2012 by IRCCS Policlinico S. Matteo
Sponsor:
Information provided by (Responsible Party):
Michele Pagani, IRCCS Policlinico S. Matteo
ClinicalTrials.gov Identifier:
NCT01186172
First received: August 17, 2010
Last updated: January 4, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Bacteremia
 Drug: Ethanol-lock therapy
Drug: Antibiotic-lock
 Phase 3

Study Type: Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics Sepsis
U.S. FDA Resources

Further study details as provided by IRCCS Policlinico S. Matteo:

Primary Outcome Measures:
  • Ratio of saved devices [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 200
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)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01186172

Contacts
Contact: Michele Pagani, MD +390382502767 m.pagani@smatteo.pv.it
Contact: Andrea Bottazzi, MD +390382502767 a.bottazzi@smatteo.pv.it

Locations
Italy
Fondazione IRCCS Policlinico "San Matteo" Recruiting
Pavia, PV, Italy, 27100
Principal Investigator: Michele Pagani, M.D.            
Sub-Investigator: Andrea Bottazzi, M.D.            
Sponsors and Collaborators
IRCCS Policlinico S. Matteo
Investigators
Principal Investigator: Michele Pagani, M.D. Fondazione IRCCS Policlinico "San Matteo" Pavia ITALY
  More Information

Publications:

Responsible Party: Michele Pagani, Dirigente Medico 1 livello, IRCCS Policlinico S. Matteo
ClinicalTrials.gov Identifier: NCT01186172     History of Changes
Other Study ID Numbers: ETHCVC
Study First Received: August 17, 2010
Last Updated: January 4, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by IRCCS Policlinico S. Matteo:
ethanol
lock therapy
vascular access
central venous catheter
sepsis

Additional relevant MeSH terms:
Bacteremia
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Ethanol
 Anti-Bacterial Agents
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 23, 2013