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Trial record 2 of 544 for:    VANCOMYCIN

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

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

Condition or disease Intervention/treatment Phase
Surgical Site Infection Vancomycin Drug: Administration of Vancomycin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preoperative Vancomycin Administration for Surgical Site Prophylaxis: Plasma and Soft Tissue Concentrations in Pediatric Neurosurgical and Orthopedic Patients
Actual Study Start Date : December 1, 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : July 20, 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Administration of Vancomycin
Administration of Vancomycin 15 mg/kg over 1 hour prior to surgical incision
Drug: Administration of Vancomycin
Intravenous Vancomycin Administration
Other Name: Vancomycin Hydrochloride

Primary Outcome Measures :
  1. 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.

  2. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   31 Days to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03453684

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United States, Colorado
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
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Principal Investigator: Melissa Brooks-Peterson, MD University of Colorado, Denver

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Responsible Party: University of Colorado, Denver Identifier: NCT03453684    
Other Study ID Numbers: 12-1411
First Posted: March 5, 2018    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018

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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
Additional relevant MeSH terms:
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Surgical Wound Infection
Wound Infection
Postoperative Complications
Pathologic Processes
Anti-Bacterial Agents
Anti-Infective Agents