NCT03453684

Pharmacokinetics of Preoperative Vancomycin

Preoperative Vancomycin Administration for Surgical Site Prophylaxis: Plasma and Soft Tissue Concentrations in Pediatric Neurosurgical and Orthopedic Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 31 Days – 18 Years
• Healthy volunteers: Not accepted

Summary

A study of plasma and tissue vancomycin pharmacokinetics in pediatric surgical patients.

Detailed description

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.

Conditions

• Surgical Site Infection
• Vancomycin

Interventions

Type	Name	Description
DRUG	Administration of Vancomycin	Intravenous Vancomycin Administration

Timeline

• Start date: 2012-12-01
• Primary completion: 2013-06-01
• Completion: 2015-07-20
• First posted: 2018-03-05
• Last updated: 2022-05-24
• Results posted: 2022-05-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study