Status:
TERMINATED
Use of a Novel Catheter Lock Solution For Treatment of Hemodialysis Catheter Infections
Lead Sponsor:
University of California, San Diego
Conditions:
Infection; Dialysis Catheter
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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 syste...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT01483872
Start Date
March 1 2012
End Date
September 1 2013
Last Update
September 6 2019
Active Locations (1)
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1
UCSD Medical Center
San Diego, California, United States, 92103