Prophylactic Antimicrobial Catheter Lock

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, double blinded, prospective, multicenter, clinical trial of the use of Heparin versus Gentamicin as a pos-dialysis catheter lock solution.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Satellite Healthcare
• Treatments: Anti-Infective Agents; Citric Acid; Gentamicins; Heparin; Sodium Citrate

Criteria

Inclusion Criteria:

• Requires placement of a central venous catheter or currently has a central venous catheter for hemodialysis access.

• Must be at least 18 years old

• Compliant with a dialysis treatment schedule

• Plans to continue hemodialysis treatment and follow-up at the investigational site

• Must be able to care for the exit site independently or have someone who is able to care for the site for them

• Must be able to sign the informed consent document

Exclusion Criteria:

• The subject who has had an infection associated with one or more positive blood cultures is not eligible until 14 days after blood cultures have become negative and clinical resolution of the episode has occurred

• Active exit site or tunnel infection

• Systemic or localized infection that is unresponsive to antibiotic therapy and/or is life threatening

• Known to have antibodies to heparin

• Allergy to pork heparin

• Allergy to gentamicin

• Subject is pregnant

• Known intravenous drug abuse