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NCT01483872 · ClinicalTrials.gov registry record · Phase 3
Use of a Novel Catheter Lock Solution For Treatment of Hemodialysis Catheter Infections
A Phase 3 study, sponsored by University of California, San Diego.
- Terminated
- Registry status
- Phase 3
- Development phase
- 9
- Enrollment target
NCT01483872: Clinical Trial Phase 3 study, sponsored by University of California, San Diego.
NCT01483872 is a Phase 3 study that was terminated before completion, run by University of California, San Diego. The registered enrollment target is 9 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01483872, a Phase 3 study, was terminated before completion, sponsored by University of California, San Diego.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 9 participants
- Enrollment target
Study 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.
Primary Outcome
Nine participants signed consent forms, only one randomized. Data was not analyzed.
Interventions
- DRUG NAC/Tigecycline/Heparin combination lock solution
- DRUG Standard anticoagulant (Heparin or Citrate)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2012-03 |
| Est. Completion | 2013-09 |
| Phase | Phase 3 |
Why NCT01483872 stopped before completion
NCT01483872 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which NAC/Tigecycline/Heparin combination lock solution is the first listed.
NCT01483872 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01483872 about?
NCT01483872 is a clinical study titled "Use of a Novel Catheter Lock Solution For Treatment of Hemodialysis Catheter Infections". 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-sal...
What is the current status of trial NCT01483872?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 9 participants. The study started on 2012-03. Estimated completion is 2013-09.
What interventions are being tested in trial NCT01483872?
The interventions under investigation include: NAC/Tigecycline/Heparin combination lock solution (DRUG), Standard anticoagulant (Heparin or Citrate) (DRUG).
Who is sponsoring clinical trial NCT01483872?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01483872's enrollment target sits among peer trials
9 1992nd of 2000 higher than 8 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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