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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Administration of Vancomycin | Experimental | Administration of Vancomycin 15 mg/kg over 1 hour prior to surgical incision |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Administration of Vancomycin | Drug | Intravenous Vancomycin Administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melissa Brooks-Peterson, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | United States |
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30 patients scheduled to undergo posterior spinal fusion 30 patients scheduled to undergo ventriculo-peritoneal (VP) shunt placement
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| ID | Title | Description |
|---|---|---|
| FG000 | Administration of Vancomycin | Administration of Vancomycin 15 mg/kg over 1 hour prior to surgical incision Administration of Vancomycin: Intravenous Vancomycin Administration |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Administration of Vancomycin | Administration of Vancomycin 15 mg/kg over 1 hour prior to surgical incision Administration of Vancomycin: Intravenous Vancomycin Administration |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | One participant was excluded because the sample was lost. | Posted | Number | L | 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). |
|
1 day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Administration of Vancomycin | Administration of Vancomycin 15 mg/kg over 1 hour prior to surgical incision Administration of Vancomycin: Intravenous Vancomycin Administration |
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Outcome measures were determined by complex mathematical modeling utilizing the pharmacokinetics estimates listed above. Outcome measures are described as necessary report the pharmacokinetic data. Outcome measures reflect the study protocol.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melissa Brooks-Peterson, MD | University of Colorado Denver | Anschutz | 30372411111 | clinicalresearchsupportcenter@ucdenver.edu |
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| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D014640 | Vancomycin |
| ID | Term |
|---|---|
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
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| 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. | 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. | 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. | 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. | 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. | 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) |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Primary | 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. | One participant was excluded because the sample was lost. | Posted | Number | L/35kg | 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). |
|
|
|
|
| Primary | 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. | One participant was excluded because the sample was lost. | Posted | Number | L/min | 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). |
|
|
|
|
| Primary | 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. | One participant was excluded because the sample was lost. | Posted | Number | L/min/1.73 m^2 | 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). |
|
|
|
|
| Primary | 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. | One participant was excluded because the sample was lost. | Posted | Number | L/35kg | 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). |
|
|
|
|
| Primary | 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. | One participant was excluded because the sample was lost. | Posted | Number | L/min/1.73m^2 | 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). |
|
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|
|
| Primary | 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. | One participant was excluded because the sample was lost. | Posted | Number | min^-1 | 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) |
|
|
|
|
| Primary | 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. | One participant was excluded because the sample was lost. | Posted | Number | Coefficient | 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) |
|
|
|
|
| Primary | 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. | One participant was excluded because the sample was lost. | Posted | Number | No unit of measure | 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) |
|
|
|
|
| Primary | 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. | One participant was excluded because the sample was lost. | Posted | Number | μg | 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) |
|
|
|
|
| 0 |
| 59 |
| 0 |
| 59 |
| 0 |
| 59 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D000602 |
| Amino Acids, Peptides, and Proteins |