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Pharmacokinetics of Preoperative Vancomycin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03453684
Recruitment Status : Completed
First Posted : March 5, 2018
Last Update Posted : October 16, 2018
Information provided by (Responsible Party):
University of Colorado, Denver

Tracking Information
First Submitted Date  ICMJE February 14, 2018
First Posted Date  ICMJE March 5, 2018
Last Update Posted Date October 16, 2018
Actual Study Start Date  ICMJE December 1, 2012
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 26, 2018)
  • Changes in Plasma levels of vancomycin [ Time Frame: At the time of the incision, 2 hrs after the incision, 4 hours after the incision, and when the incision is closed. ]
    Plasma levels of vancomycin will be evaluated periodically during the surgical procedure.
  • Changes to vancomycin at the skin level [ Time Frame: At the time of the incision and at the time the incision is closed. ]
    Are there changes in vancomycin at the skin levels will be evaluated during the surgical procedure.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Pharmacokinetics of Preoperative Vancomycin
Official Title  ICMJE Preoperative Vancomycin Administration for Surgical Site Prophylaxis: Plasma and Soft Tissue Concentrations in Pediatric Neurosurgical and Orthopedic Patients
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Surgical Site Infection
  • Vancomycin
Intervention  ICMJE Drug: Administration of Vancomycin
Intravenous Vancomycin Administration
Other Name: Vancomycin Hydrochloride
Study Arms  ICMJE Experimental: Administration of Vancomycin
Administration of Vancomycin 15 mg/kg over 1 hour prior to surgical incision
Intervention: Drug: Administration of Vancomycin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 26, 2018)
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 20, 2015
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 31 Days to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT03453684
Other Study ID Numbers  ICMJE 12-1411
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Colorado, Denver
Study Sponsor  ICMJE University of Colorado, Denver
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Melissa Brooks-Peterson, MD University of Colorado, Denver
PRS Account University of Colorado, Denver
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP