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

Stopped early · Phase 3

Conditions studied: Infection; Dialysis Catheter

In brief

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.

Key facts

Study ID

NCT01483872

Run by

University of California, San Diego

People needed

9

Starts

2012-03-01

Expected to finish

2013-09-01

Last updated by the study team

2019-09-06

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Any adult (≥ 18 years of age) who has ESRD and a prevalent or incident tunneled hemodialysis catheter and expected to continue hemodialysis for 3 months will be eligible for enrollment.

You may not qualify if…

• The following patients will be excluded from study entry:
• patient is unable (and no guardian or legal representative is available) or unwilling to provide informed consent and
• patient is allergic to NAC, tigecycline, minocycline, or heparin.
• The following patients will be excluded from randomization:
• patient has evidence of a complicated bacteremia such as endocarditis, septic thrombophlebitis, septic emboli, osteomyelitis, deep seated abscess, or hypotension requiring use of vasopressors,
• patient has evidence of an exit site infection around the catheter such as a pus pocket, purulent drainage, or erythema,
• patient is pregnant or will become pregnant,
• the infection is due to an organism that is resistant to tigecycline such as Candida or Pseudomonas species.

Where it is running

• UCSD Medical Center — San Diego, California, United States

Full record on ClinicalTrials.gov

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