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

End-Stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00614679
• Other study ID #: H-17624
• Status: Completed
• Phase: Phase 1
• Start date: October 2006
• Est. completion date: December 2009

Study information

• Verified date: October 2019
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bacteremia
• Catheter-Related Infections
• End-Stage Renal Disease
• Hemodialysis Catheter-associated Infection
• Kidney Failure, Chronic

Intervention

Drug:
• catheter lock solution consisting of N-acetylcystein, tigecycline and heparin
N-acetylcystein 80 mg/ml, tigecycline 1 mg/ml, and heparin 2000 units/ml. This will be a 5 ml catheter lock solution

Locations

Country	Name	City	State
United States	Ben Taub General Hospital	Houston	Texas
United States	Michael E. DeBakey VA Medical Center	Houston	Texas
United States	The Methodist Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment success within 90 days		90 days
Secondary	catheter salvage		90 days