Phase 4
Completed N=303
Prophylactic Antimicrobial Catheter Lock
Source: ClinicalTrials.gov NCT00571259 ↗Enrolled (actual)
303
Serious AEs
17.2%
Results posted
Sep 2021
Primary outcomePrimary: Rate of Device-related Bacteremia — 30; 11 Number of infections
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This is a randomized, double blinded, prospective, multicenter, clinical trial of the use of Heparin versus Gentamicin as a pos-dialysis catheter lock solution.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Device-related Bacteremia |
30; 11 | — |
| SECONDARY Rate of Catheter Clotting Measured as Requirement for tPA Usage to Maintain Blood Flow |
3.42; 2.36 | — |
Eligibility Criteria
Inclusion Criteria
- Requires placement of a central venous catheter or currently has a central venous catheter for hemodialysis access.
- Must be at least 18 years old
- Compliant with a dialysis treatment schedule
- Plans to continue hemodialysis treatment and follow-up at the investigational site
- Must be able to care for the exit site independently or have someone who is able to care for the site for them
- Must be able to sign the informed consent document
Exclusion Criteria
- The subject who has had an infection associated with one or more positive blood cultures is not eligible until 14 days after blood cultures have become negative and clinical resolution of the episode has occurred
- Active exit site or tunnel infection
- Systemic or localized infection that is unresponsive to antibiotic therapy and/or is life threatening
- Known to have antibodies to heparin
- Allergy to pork heparin
- Allergy to gentamicin
- Subject is pregnant
- Known intravenous drug abuse
Data sourced from ClinicalTrials.gov (NCT00571259). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.