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

Phase 1

Completed

• Conditions: End-Stage Renal Disease; Hemodialysis Catheter-associated Infection
• Interventions: Drug: catheter lock solution consisting of N-acetylcystein, tigecycline and heparin

• Registration Number: NCT00614679
• Lead Sponsor: University of California, San Diego

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2008-02-11
• Study First Submitted QC: 2008-02-11
• Study First Posted: 2008-02-13
• Primary Completion: 2008-12
• Study Completion: 2009-12
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-07
• Last Update Posted: 2019-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	catheter lock solution consisting of N-acetylcystein, tigecycline and heparin	single arm trial of experimental catheter lock solution

Primary Outcome Measures

Name	Time	Method
Treatment success within 90 days	90 days

Secondary Outcome Measures

Name	Time	Method
catheter salvage	90 days

Trial Locations

Locations (3)

Ben Taub General Hospital; 🇺🇸 Houston, Texas, United States

The Methodist Hospital; 🇺🇸 Houston, Texas, United States

Michael E. DeBakey VA Medical Center; 🇺🇸 Houston, Texas, United States