A Phase 4 interventional study of Administration of Vancomycin in Surgical Site Infection and Vancomycin, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to participants aged 31 Days to 18 Years. Per ClinicalTrials.gov, last updated 2022-05-24.
Sponsored by University of Colorado, Denver · Phase 4, Interventional, and Treatment
A study of plasma and tissue vancomycin pharmacokinetics in pediatric surgical patients.
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.
Exclusion Criteria:
Administration of Vancomycin 15 mg/kg over 1 hour prior to surgical incision
Drug: Administration of Vancomycin
Intravenous Vancomycin Administration
Also known as: Vancomycin Hydrochloride
Pharmacokinetics Analysis: V˅c
Volume of the central compartment. This outcome measure was pre-specified to utilize advanced mathematical modeling for this assessment. No measure of central tendency is available.
Time frame: 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).
Pharmacokinetics Analysis: V˅2
Volume of the peripheral compartment Typical value. This outcome measure was pre-specified to utilize advanced mathematical modeling for this assessment. No measure of central tendency is available.
Time frame: 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).
Pharmacokinetics Analysis: Q
Intercompartmental clearance between central compartment (Vc) and peripheral compartment (V2) Typical Value. This outcome measure was pre-specified to utilize advanced mathematical modeling for this assessment. No measure of central tendency is available.
Time frame: 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).
Pharmacokinetics Analysis: Cle
Elimination clearance. This outcome measure was pre-specified to utilize advanced mathematical modeling for this assessment. No measure of central tendency is available.
Time frame: 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).
Pharmacokinetics Analysis: sf˅V2
Scaling Factor for Body weight covariate for V2 (Volume of the peripheral compartment) Typical Value. This outcome measure was pre-specified to utilize advanced mathematical modeling for this assessment. No measure of central tendency is available.
Time frame: 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).
Pharmacokinetics Analysis: sf˅Cle
Scaling Factor for Body weight covariate for Cle (elimination clearance) Typical Value. This outcome measure was pre-specified to utilize advanced mathematical modeling for this assessment. No measure of central tendency is available.
Time frame: 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).
Pharmacokinetics Analysis: K˅skin0
Accounts for the equilibration rate between plasma and skin. Typical Value should be read as 3.6E-05. This outcome measure was pre-specified to utilize advanced mathematical modeling for this assessment. No measure of central tendency is available.
Time frame: 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)
Pharmacokinetics Analysis: PC
Partition coefficient, models skin drug concentration between plasma and skin. This outcome measure was pre-specified to utilize advanced mathematical modeling for this assessment. No measure of central tendency is available.
Time frame: 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)
Pharmacokinetics Analysis: δ ˅R-plasma
Proportional or relative intrasubject variability for plasma data Typical Value. There is no unit of measure for this measurement. This outcome measure was pre-specified to utilize advanced mathematical modeling for this assessment. No measure of central tendency is available.
Time frame: 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)
Pharmacokinetics Analysis: δ ˅A-skin
Additive intrasubject variability for skin data Typical Value. This outcome measure was pre-specified to utilize advanced mathematical modeling for this assessment. No measure of central tendency is available.
Time frame: 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)
30 patients scheduled to undergo posterior spinal fusion 30 patients scheduled to undergo ventriculo-peritoneal (VP) shunt placement
| Milestone | Administration of Vancomycin |
|---|---|
| Started | 60 |
| Completed | 60 |
| Not completed | 0 |
Volume of the central compartment. This outcome measure was pre-specified to utilize advanced mathematical modeling for this assessment. No measure of central tendency is available.
| L | Administration of Vancomycin |
|---|---|
| Typical value | 2.56 |
| w^2 | 1.14 |
Volume of the peripheral compartment Typical value. This outcome measure was pre-specified to utilize advanced mathematical modeling for this assessment. No measure of central tendency is available.
| L/35kg | Administration of Vancomycin |
|---|---|
| Pharmacokinetics Analysis: V˅2 | 5.30 |
Intercompartmental clearance between central compartment (Vc) and peripheral compartment (V2) Typical Value. This outcome measure was pre-specified to utilize advanced mathematical modeling for this assessment. No measure of central tendency is available.
| L/min | Administration of Vancomycin |
|---|---|
| Pharmacokinetics Analysis: Q | 0.12 |
Elimination clearance. This outcome measure was pre-specified to utilize advanced mathematical modeling for this assessment. No measure of central tendency is available.
| L/min/1.73 m^2 | Administration of Vancomycin |
|---|---|
| Typical value | 0.09 |
| ꙍ^2 (Intersubject variability) | 0.13 |
Scaling Factor for Body weight covariate for V2 (Volume of the peripheral compartment) Typical Value. This outcome measure was pre-specified to utilize advanced mathematical modeling for this assessment. No measure of central tendency is available.
| L/35kg | Administration of Vancomycin |
|---|---|
| Pharmacokinetics Analysis: sf˅V2 | 1.01 |
Scaling Factor for Body weight covariate for Cle (elimination clearance) Typical Value. This outcome measure was pre-specified to utilize advanced mathematical modeling for this assessment. No measure of central tendency is available.
| L/min/1.73m^2 | Administration of Vancomycin |
|---|---|
| Pharmacokinetics Analysis: sf˅Cle | 1.69 |
Accounts for the equilibration rate between plasma and skin. Typical Value should be read as 3.6E-05. This outcome measure was pre-specified to utilize advanced mathematical modeling for this assessment. No measure of central tendency is available.
| min^-1 | Administration of Vancomycin |
|---|---|
| Typical value | 3.6 |
| ꙍ^2 (Intersubject variability) | 2.0 |
Partition coefficient, models skin drug concentration between plasma and skin. This outcome measure was pre-specified to utilize advanced mathematical modeling for this assessment. No measure of central tendency is available.
| Coefficient | Administration of Vancomycin |
|---|---|
| Typical value | 32.0 |
| ꙍ^2 (Intersubject variability) | 3.7 |
Proportional or relative intrasubject variability for plasma data Typical Value. There is no unit of measure for this measurement. This outcome measure was pre-specified to utilize advanced mathematical modeling for this assessment. No measure of central tendency is available.
| No unit of measure | Administration of Vancomycin |
|---|---|
| Pharmacokinetics Analysis: δ ˅R-plasma | 0.23 |
Additive intrasubject variability for skin data Typical Value. This outcome measure was pre-specified to utilize advanced mathematical modeling for this assessment. No measure of central tendency is available.
| μg | Administration of Vancomycin |
|---|---|
| Pharmacokinetics Analysis: δ ˅A-skin | 7.5 |
Collected over 1 day. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Administration of Vancomycin | 0/59 (0%) | 0/59 (0%) | 0/59 (0%) |
| Age, Categorical(Participants) | Administration of Vancomycin |
|---|---|
| <=18 years | 57 |
| Between 18 and 65 years | 2 |
| >=65 years | 0 |
| Age, Continuous(years) | Administration of Vancomycin |
|---|---|
| Mean | 7.8 ± 5.9 |
| Sex: Female, Male(Participants) | Administration of Vancomycin |
|---|---|
| Female | 37 |
| Male | 22 |
| Race and Ethnicity Not Collected(Participants) | Administration of Vancomycin |
|---|
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University of Colorado, Denver