Overview

Use of a Novel Catheter Lock Solution For Treatment of Hemodialysis Catheter Infections

Status:
Terminated
Trial end date:
2013-09-01
Target enrollment:
Participant gender:
Summary
Aim: To conduct a randomized, double-blinded, controlled phase II trial to investigate the use of a catheter lock solution consisting of N-acetylcysteine, tigecycline and heparin, in addition to systemic antibiotics, for the treatment of hemodialysis catheter-associated bacteremia via a catheter-salvage strategy. The investigators plan to randomize 102 patients with hemodialysis catheter-associated bacteremia to one of two treatment arms. All patients will receive systemic antibiotics for treatment of their infection. Additionally, patients randomized to the interventional arm will also receive a catheter lock solution consisting of N-acetylcysteine, tigecycline and heparin for 2 weeks with the aim of salvaging the catheter. The control arm will receive only an anticoagulant solution as a catheter lock which is standard of care - this can be either heparin or citrate (depending on what agent is standard of care for a particular patient). The main outcome of interest is successful treatment which is defined as a resolution of the current episode of bacteremia as well as lack of recurrent bacteremia within 90 days of follow-up.
Phase:
Phase 3
Details
Lead Sponsor:
University of California, San Diego
Treatments:
Anticoagulants
Calcium heparin
Citric Acid
Heparin
Pharmaceutical Solutions
Tigecycline