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

Study Overview
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Brief Summary
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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.

Official Title
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Phase II Trial of a Novel Catheter Lock Solution For Adjunctive Treatment of Hemodialysis Catheter-Associated Bacteremia.

Conditions
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Infection; Dialysis Catheter

Intervention / Treatment
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* Drug: NAC/Tigecycline/Heparin combination lock solution
* Drug: Standard anticoagulant (Heparin or Citrate)


Participation Criteria
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Eligibility Criteria
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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: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NAC/Tigecycline/Heparin combination lock solution<br>A combination of the above three drugs will form the catheter lock solution that will be instilled into the catheter | Drug: NAC/Tigecycline/Heparin combination lock solution<br> <br> |
| Placebo Comparator: Standard anticoagulant (heparin or citrate)<br>Standard anticoagulant (heparin or citrate) | Drug: Standard anticoagulant (Heparin or Citrate)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success Rate | Nine participants signed consent forms, only one randomized. Data was not analyzed. | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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salvage infected hemodialysis catheters, novel catheter lock solution