Status:
COMPLETED
Pharmacokinetics of Preoperative Vancomycin
Lead Sponsor:
University of Colorado, Denver
Conditions:
Surgical Site Infection
Vancomycin
Eligibility:
All Genders
31-18 years
Phase:
PHASE4
Brief 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 with...
Eligibility Criteria
Inclusion
- Neurosurgery patients between the ages of 31 days up to 18 years
- Receiving a single dose of vancomycin administered prior to surgery for cerebrospinal fluid (CSF) shunt placement or revision.
- Orthopedic surgical patients between the ages of 31 days up to 18 years
- Receiving a single dose of vancomycin administered prior to surgery for definitive spinal fusion.
Exclusion
- Patients already receiving vancomycin for treatment of an active infection,
- Patients who have a Creatinine ≥1.2,
- Patients who's creatinine clearance less than 50,
- Known chronic renal failure and are on dialysis,
- Patients with a known allergy to vancomycin, not including Red Man Syndrome.
Key Trial Info
Start Date :
December 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 20 2015
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03453684
Start Date
December 1 2012
End Date
July 20 2015
Last Update
May 24 2022
Active Locations (1)
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1
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045