Pharmacokinetics of Preoperative Vancomycin

University of Colorado Denver (CU Denver)

Status and phase: Completed; Phase 4

Conditions: Vancomycin; Surgical Site Infection

Treatments: Drug: Administration of Vancomycin

Study type: Interventional

Funder types: Other

Identifiers

NCT03453684

12-1411

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 31 days to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Neurosurgery patients between the ages of 31 days up to 18 years
2. Receiving a single dose of vancomycin administered prior to surgery for cerebrospinal fluid (CSF) shunt placement or revision.
3. Orthopedic surgical patients between the ages of 31 days up to 18 years
4. Receiving a single dose of vancomycin administered prior to surgery for definitive spinal fusion.

Exclusion criteria

1. Patients already receiving vancomycin for treatment of an active infection,
2. Patients who have a Creatinine ≥1.2,
3. Patients who's creatinine clearance less than 50,
4. Known chronic renal failure and are on dialysis,
5. Patients with a known allergy to vancomycin, not including Red Man Syndrome.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Administration of Vancomycin

Experimental group

Description:

Administration of Vancomycin 15 mg/kg over 1 hour prior to surgical incision

Treatment:

Drug: Administration of Vancomycin