Hemodialysis Catheter-related Bacteremia Clinical Trial
Official title:
RCT for the Treatment of Hemodialysis Catheter-Related Bacteremia
Patients who undergo hemodialysis via a tunneled catheter often develop bloodstream
infections that arise from the catheter. There are several management options for treatment
of such an infection, though the best option is not clearly delineated. Standard of care
options include exchanging the catheter for a new one over a guide-wire and instilling a
high concentration of an antibiotic directly into the catheter lumen. The investigators are
planning to treat hemodialysis catheter bloodstream infections by one of two strategies: 1.
Use of a novel antibiotic lock solution Or 2. Changing out the infected catheter for a new
one. Both these options have comparable cure rates as shown in the medical literature. After
obtaining informed consent, patients will be randomized to either treatment arm and will
continue to receive all other standard medical care.
Specific Aim: To conduct a randomized clinical trial to demonstrate that the use of a novel
antibiotic lock solution (consisting of N-acetylcysteine, tigecycline and heparin) is
non-inferior to guide-wire exchange in the treatment of hemodialysis catheter-related
bacteremia.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | January 2017 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 100 Years |
| Eligibility |
Inclusion Criteria: - Any adult (= 18 years of age) who has ESRD and a prevalent or incident tunneled hemodialysis catheter with bacteremia will be eligible for enrollment. Exclusion Criteria: - The following patients will be excluded: 1) patient is unable (and no guardian or legal representative is available) or unwilling to provide informed consent, 2) patient is allergic to NAC, tigecycline, minocycline, or heparin, 3) patient has evidence of a complicated bacteremia such as endocarditis, septic thrombophlebitis, septic emboli, osteomyelitis, deep seated abscess, or hypotension requiring use of vasopressors, 4) patient has evidence of an exit site infection around the catheter such as a pus pocket, purulent drainage, or erythema, 5) patient is pregnant or will become pregnant, 6) the infection is due to an organism that is resistant to tigecycline such as Candida or Pseudomonas species. |
Allocation: Randomized, Masking: Open Label
| Country | Name | City | State |
|---|---|---|---|
| United States | University of California, San Diego Medical Center | San Diego | California |
| Lead Sponsor | Collaborator |
|---|---|
| University of California, San Diego | National Institutes of Health (NIH) |
United States,
Aslam S, Trautner BW, Ramanathan V, Darouiche RO. Pilot trial of N-acetylcysteine and tigecycline as a catheter-lock solution for treatment of hemodialysis catheter-associated bacteremia. Infect Control Hosp Epidemiol. 2008 Sep;29(9):894-7. doi: 10.1086/590192. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Treatment Success | The primary outcome is successful treatment of infection defined as clinical and microbiologic resolution of the initial bacteremia with absence of persistent or recurrent catheter-related bacteremia at day 28 (one week after end of treatment). | 28 days | No |