Infection; Dialysis Catheter
Conditions
Keywords
salvage infected hemodialysis catheters, novel catheter lock solution
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.
Interventions
DRUGNAC/Tigecycline/Heparin combination lock solution
DRUGStandard anticoagulant (Heparin or Citrate)
Sponsors
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success Rate | 90 days | Nine participants signed consent forms, only one randomized. Data was not analyzed. |
Countries
United States
Participant flow
Pre-assignment details
9 patients signed consent forms. Only one developed an active infection and thus underwent randomization.
Participants by arm
| Arm | Count |
|---|---|
| All Participants | 9 |
| Total | 9 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1 |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
Primary
Success Rate
Nine participants signed consent forms, only one randomized. Data was not analyzed.
Time frame: 90 days
Population: Nine participants signed consent forms, only one randomized. Data was not analyzed.