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

Primary Purpose

Bacteremia

Status

Unknown status

Phase

Phase 3

Locations

Italy

Study Type

Interventional

Intervention

Ethanol-lock therapy

Antibiotic-lock

About this trial

This is an interventional treatment trial for Bacteremia focused on measuring ethanol, lock therapy, vascular access, central venous catheter, sepsis

Eligibility Criteria

1 Year - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Fondazione IRCCS Policlinico "San Matteo"Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ethanol-lock

Antibiotic lock

Arm Description

Treatment with a combination of ethanol-lock and parenteral therapy

Treatment with a combination of antibiotic-lock and parenteral therapy

Outcomes

Primary Outcome Measures

Ratio of saved devices

Secondary Outcome Measures

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.

Number of patients with proper parenteral therapy

Verified by an Infectious Diseases Specialist

Ratio of saved devices

Time for next bacteriemic episode

Full Information

NCT ID

NCT01186172

First Posted

August 17, 2010

Last Updated

January 4, 2012

Sponsor

IRCCS Policlinico S. Matteo

1. Study Identification

Unique Protocol Identification Number

NCT01186172

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2012

Overall Recruitment Status

Unknown status

Study Start Date

June 2010 (undefined)

Primary Completion Date

December 2012 (Anticipated)

Study Completion Date

June 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

IRCCS Policlinico S. Matteo

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bacteremia

Keywords

ethanol, lock therapy, vascular access, central venous catheter, sepsis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Ethanol-lock

Arm Type

Experimental

Arm Description

Treatment with a combination of ethanol-lock and parenteral therapy

Arm Title

Antibiotic lock

Arm Type

Active Comparator

Arm Description

Treatment with a combination of antibiotic-lock and parenteral therapy

Intervention Type

Drug

Intervention Name(s)

Ethanol-lock therapy

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Antibiotic-lock

Intervention Description

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.

Primary Outcome Measure Information:

Title

Ratio of saved devices

Time Frame

7 days

Secondary Outcome Measure Information:

Title

Number of participants with adverse events linked to ethanol lock as a measure of safety and tolerability

Description

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.

Time Frame

60 days

Title

Number of patients with proper parenteral therapy

Description

Verified by an Infectious Diseases Specialist

Time Frame

7 days

Title

Ratio of saved devices

Time Frame

15-30-60 days

Title

Time for next bacteriemic episode

Time Frame

30 days after the end of lock

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Accepts Healthy Volunteers

Eligibility 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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Michele Pagani, MD

Phone

+390382502767

m.pagani@smatteo.pv.it

First Name & Middle Initial & Last Name or Official Title & Degree

Andrea Bottazzi, MD

Phone

+390382502767

a.bottazzi@smatteo.pv.it

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michele Pagani, M.D.

Organizational Affiliation

Fondazione IRCCS Policlinico San Matteo, Pavia, Italy

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fondazione IRCCS Policlinico "San Matteo"

City

Pavia

State/Province

ZIP/Postal Code

27100

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Michele Pagani, M.D.

First Name & Middle Initial & Last Name & Degree

Andrea Bottazzi, M.D.

12. IPD Sharing Statement

Citations:

PubMed Identifier

19803767

Citation

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.

Results Reference

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

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