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NCT01619982 · ClinicalTrials.gov registry record · Phase 4
Pre-operative Prophylaxis With Vancomycin and Cefazolin in Pediatric Cardiovascular Surgery Patients
A Phase 4 study, sponsored by Stanford University.
- Completed
- Registry status
- Phase 4
- Development phase
- 32
- Enrollment target
NCT01619982: Completed Phase 4 study, sponsored by Stanford University.
NCT01619982 is a Phase 4 study that has completed, run by Stanford University. The registered enrollment target is 32 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01619982, a Phase 4 study, has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 32 participants
- Enrollment target
Study Summary
The investigators hope to learn 1) if the addition of prophylaxis with vancomycin will decrease the rate of cefazolin non-susceptible surgical site infections (SSI), in high risk population 2) to develop better understanding of vancomycin and cefazolin pharmacokinetics in children undergoing cardiopulmonary bypass (CPB) 3) to assess the barriers to vancomycin dosing peri-operatively 4) to assess side effects and risks associated with peri-operative vancomycin administration. This will allow us to improve patient care by better understanding the benefits or the risks of peri-operative vancomycin administration and potentially decrease cefazolin-resistant surgical site infections. In addition, this study gives us the opportunity to evaluate cefazolin and vancomycin pharmacokinetics (pK) on children on CPB. The investigators will take blood samples from 20 patients. In 10 patients the investigators will do Cefazolin pK analysis and in the other 10 the investigators will do pK Vancomycin analysis. For the remainder of 292 patients, only prospective chart review will be done to determine the incidence of SSIs. This data will be compared with 936 controls who received only Cefazolin pre-operatively as prophylaxis for SSI's. \--------------------------------------------------------------------------------
Interventions
- DRUG Cefazolin 25 mg/kg body weight and Vancomycin hydrochloride
- DRUG Cefazolin 30 mg/kg body weight
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2012-02 |
| Est. Completion | 2014-12 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01619982
The ClinicalTrials.gov registry entry for NCT01619982 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stanford University, which has 1,744 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Cefazolin 25 mg/kg body weight and Vancomycin hydrochloride is the first listed.
NCT01619982 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01619982 about?
NCT01619982 is a clinical study titled "Pre-operative Prophylaxis With Vancomycin and Cefazolin in Pediatric Cardiovascular Surgery Patients". The investigators hope to learn 1) if the addition of prophylaxis with vancomycin will decrease the rate of cefazolin non-susceptible surgical site infections (SSI), in high risk population 2) to develop better understanding of vancomycin and cefazolin pharmacokinetics in children undergoing cardiop...
What is the current status of trial NCT01619982?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 32 participants. The study started on 2012-02. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01619982?
The interventions under investigation include: Cefazolin 25 mg/kg body weight and Vancomycin hydrochloride (DRUG), Cefazolin 30 mg/kg body weight (DRUG).
Who is sponsoring clinical trial NCT01619982?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
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