A Novel Catheter Lock Solution for Treatment of Tunneled Hemodialysis Catheter-Associated Bacteremia

University of California, San Diego3 sites in 1 country18 target enrollmentOctober 2006

ConditionsEnd-Stage Renal Disease Hemodialysis Catheter-associated Infection

Interventionscatheter lock solution consisting of N-acetylcystein, tigecycline and heparin

Drugscatheter lock solution consisting of N-acetylcystein, tigecycline and heparin

Overview

Phase: Phase 1
Intervention: catheter lock solution consisting of N-acetylcystein, tigecycline and heparin
Conditions: End-Stage Renal Disease
Sponsor: University of California, San Diego
Enrollment: 18
Locations: 3
Primary Endpoint: Treatment success within 90 days
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective is to investigate the ability of systemic intravenous antibiotic plus antibiotic/anti-biofilm (i.e. N-acetylcysteine) lock catheter technique in eradicating uncomplicated catheter associated bacteremia and salvaging the infected vascular catheter. Secondary objectives include duration to clearance of bacteremia, future recurrence of bacteremia, need for catheter removal and death.

Registry

clinicaltrials.gov

Start Date

October 2006

End Date

December 2009

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of California, San Diego

Responsible Party

Principal Investigator

Saima Aslam

Associate Professor

University of California, San Diego

Eligibility Criteria

Inclusion Criteria

•Adult patients who have an indwelling hemodialysis catheter for 10 or more days and evidence of a catheter associated bloodstream infection as evidenced by 1)quantitative blood cultures obtained through the lumen of the catheter yield concentrations of bacterial colonies that are 5 or more fold higher than peripheral blood cultures, or 2)blood cultures obtained through the lumen of the catheter becomes positive 2 or more hours earlier than peripheral blood cultures.

Exclusion Criteria

•Patients will be excluded if 1) they are unable or unwilling to provide informed consent, 2) have evidence of a complicated bacteremia such as endocarditis, septic thrombophlebitis, septic emboli, osetoemylitis, deep seated abscesses etc 3)evidence of an exit site infection around the catheter such as a pus pocket, drainage or erythema. 4) patient is allergic to NAC or the proposed antibiotic (if patient is allergic to minocycline, tigecycline will not be used). 5) patient is pregnant or will become pregnant.