Use of a Novel Catheter Lock Solution For Treatment of Hemodialysis Catheter Infections
Condition: Infection; Dialysis Catheter
MeSH terms: Infections
Intervention: NAC/Tigecycline/Heparin combination lock solution; Standard anticoagulant (Heparin or Citrate)
Intervention MeSH terms: Tigecycline; Heparin; Calcium heparin; Anticoagulants
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: salvage infected hemodialysis catheters; novel catheter lock solution

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.
    

Eligibility criteria:

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