Pharmacokinetics of Preoperative Vancomycin

NCT ID: NCT03453684

Last Updated: 2022-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-01
• Study Completion Date: 2015-07-20

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 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Administration of Vancomycin

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

Group Type: EXPERIMENTAL

Administration of Vancomycin

Intervention Type: DRUG

Intravenous Vancomycin Administration

Interventions

Administration of Vancomycin

Intravenous Vancomycin Administration

Intervention Type: DRUG

Other Intervention Names

Vancomycin Hydrochloride

Eligibility Criteria

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.

• Minimum Eligible Age: 31 Days
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Melissa Brooks-Peterson, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Countries

United States

Other Identifiers

12-1411

Identifier Type: -

Identifier Source: org_study_id