Conditions: Infection; Dialysis Catheter
Keywords: salvage infected hemodialysis catheters novel catheter lock solution
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 9
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: A combination of the above three drugs will form the catheter lock solution that will be instilled into the catheter arm 2: Standard anticoagulant (heparin or citrate)

Interventions: intervention 1: NAC/Tigecycline/Heparin combination lock solution intervention 2: Standard anticoagulant (Heparin or Citrate)
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: