Clinical trial NCT03453684: Pharmacokinetics of Preoperative Vancomycin
Official title: Preoperative Vancomycin Administration for Surgical Site Prophylaxis: Plasma and Soft Tissue Concentrations in Pediatric Neurosurgical and Orthopedic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Surgical Site Infection
Vancomycin
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2018-03-05
Enrollment: 60
Sex: ALL
Minimum age (years): 31
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pharmacokinetics Analysis: V˅c
timeFrame: 1 Day (measured and combined from the time of the incision, through 2 hours after the incision, 4 hours after the incision, until when the incision is closed).
measure: Pharmacokinetics Analysis: V˅2
timeFrame: 1 Day (measured and combined from the time of the incision, through 2 hours after the incision, 4 hours after the incision, until when the incision is closed).
measure: Pharmacokinetics Analysis: Q
timeFrame: 1 Day (measured and combined from the time of the incision, through 2 hours after the incision, 4 hours after the incision, until when the incision is closed).
measure: Pharmacokinetics Analysis: Cle
timeFrame: 1 Day (measured and combined from the time of the incision, through 2 hours after the incision, 4 hours after the incision, until when the incision is closed).
measure: Pharmacokinetics Analysis: sf˅V2
timeFrame: 1 Day (measured and combined from the time of the incision, through 2 hours after the incision, 4 hours after the incision, until when the incision is closed).
measure: Pharmacokinetics Analysis: sf˅Cle
timeFrame: 1 Day (measured and combined from the time of the incision, through 2 hours after the incision, 4 hours after the incision, until when the incision is closed).
measure: Pharmacokinetics Analysis: K˅skin0
timeFrame: 1 Day (measured and combined from the time of the incision, through 2 hours after the incision, 4 hours after the incision, until when the incision is closed)
measure: Pharmacokinetics Analysis: PC
timeFrame: 1 Day (measured and combined from the time of the incision, through 2 hours after the incision, 4 hours after the incision, until when the incision is closed)
measure: Pharmacokinetics Analysis: δ ˅R-plasma
timeFrame: 1 Day (measured and combined from the time of the incision, through 2 hours after the incision, 4 hours after the incision, until when the incision is closed)
measure: Pharmacokinetics Analysis: δ ˅A-skin
timeFrame: 1 Day (measured and combined from the time of the incision, through 2 hours after the incision, 4 hours after the incision, until when the incision is closed)
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Melissa Brooks-Peterson, MD
role: PRINCIPAL_INVESTIGATOR
References: