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

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.

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Key information

Conditions

End-stage Renal Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hemodialysis Catheter-associated Infection Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Ben Taub General Hospital, Houston, Texas, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

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

Primary outcomes

Treatment success within 90 days

Time frame: 90 days

Secondary outcomes

catheter salvage

Time frame: 90 days

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Important dates

Study start: 2006
Primary completion: 2008
Study completion: 2009
First posted: Feb 13, 2008
Registry last updated: Oct 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed