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The study was stopped due to poor enrollment.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NAC/Tigecycline/Heparin combination lock solution | Experimental | A combination of the above three drugs will form the catheter lock solution that will be instilled into the catheter |
|
| Standard anticoagulant (heparin or citrate) | Placebo Comparator | Standard anticoagulant (heparin or citrate) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NAC/Tigecycline/Heparin combination lock solution | Drug |
| ||
| Standard anticoagulant (Heparin or Citrate) |
| Measure | Description | Time Frame |
|---|---|---|
| Success Rate | Nine participants signed consent forms, only one randomized. Data was not analyzed. | 90 days |
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Inclusion Criteria:
Exclusion Criteria:
The following patients will be excluded from study entry:
The following patients will be excluded from randomization:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSD Medical Center | San Diego | California | 92103 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35363884 | Derived | Almeida BM, Moreno DH, Vasconcelos V, Cacione DG. Interventions for treating catheter-related bloodstream infections in people receiving maintenance haemodialysis. Cochrane Database Syst Rev. 2022 Apr 1;4(4):CD013554. doi: 10.1002/14651858.CD013554.pub2. |
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9 patients signed consent forms. Only one developed an active infection and thus underwent randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | NAC/Tigecycline/Heparin Combination Lock Solution | A combination of the above three drugs will form the catheter lock solution that will be instilled into the catheter NAC/Tigecycline/Heparin combination lock solution |
| FG001 | Standard Anticoagulant (Heparin or Citrate) | Standard anticoagulant (heparin or citrate) Standard anticoagulant (Heparin or Citrate) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Success Rate | Nine participants signed consent forms, only one randomized. Data was not analyzed. | Nine participants signed consent forms, only one randomized. Data was not analyzed. | Posted | 90 days |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants | Nine participants signed consent forms, only one randomized. Data was not analyzed. |
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Nine participants signed consent forms, only one randomized. Study terminated due to low enrollment. Data was not analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Saima Aslam | UCSD | 858 657 7463 | saslam@ucsd.edu |
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| ID | Term |
|---|---|
| D007239 | Infections |
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| ID | Term |
|---|---|
| D006493 | Heparin |
| D019343 | Citric Acid |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D002951 | Citrates |
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| Drug |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
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| D014233 |
| Tricarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |