Pharmacokinetics of Preoperative Vancomycin
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|ClinicalTrials.gov Identifier: NCT03453684|
Recruitment Status : Completed
First Posted : March 5, 2018
Last Update Posted : October 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Surgical Site Infection Vancomycin||Drug: Administration of Vancomycin||Phase 4|
Background: Vancomycin is used for antibiotic prophylaxis in pediatric surgical patients without a complete understanding of plasma and soft tissue pharmacokinetics. Guidelines recommend incision within 60 minutes after administration; however, tissue concentrations of vancomycin at that early time may not be therapeutic. The Investigators conducted a study of plasma and tissue concentrations in pediatric neurosurgical and orthopedic patients to characterize intraoperative vancomycin pharmacokinetics.
Patients, ages (0.1-18.8 years), undergoing posterior spinal fusion (n=30) or ventriculoperitoneal shunt placement (n=30), received intravenous vancomycin 15 mg/kg over one hour. Skin biopsies were taken at incision and skin closure. Blood samples were also collected at incision and closure; additional samples were drawn at 2- and 4-hours if patient was still in surgery. Population pharmacokinetic (PK) analysis was performed to characterize PK parameter estimates and to develop a model of intraoperative plasma and tissue vancomycin concentrations vs. time.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Preoperative Vancomycin Administration for Surgical Site Prophylaxis: Plasma and Soft Tissue Concentrations in Pediatric Neurosurgical and Orthopedic Patients|
|Actual Study Start Date :||December 1, 2012|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||July 20, 2015|
Experimental: Administration of Vancomycin
Administration of Vancomycin 15 mg/kg over 1 hour prior to surgical incision
Drug: Administration of Vancomycin
Intravenous Vancomycin Administration
Other Name: Vancomycin Hydrochloride
- Changes in Plasma levels of vancomycin [ Time Frame: At the time of the incision, 2 hrs after the incision, 4 hours after the incision, and when the incision is closed. ]Plasma levels of vancomycin will be evaluated periodically during the surgical procedure.
- Changes to vancomycin at the skin level [ Time Frame: At the time of the incision and at the time the incision is closed. ]Are there changes in vancomycin at the skin levels will be evaluated during the surgical procedure.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03453684
|United States, Colorado|
|University of Colorado Anschutz Medical Campus|
|Aurora, Colorado, United States, 80045|
|Principal Investigator:||Melissa Brooks-Peterson, MD||University of Colorado, Denver|