Trial Outcomes & Findings for Pharmacokinetics of Preoperative Vancomycin (NCT NCT03453684)

NCT ID: NCT03453684

Last Updated: 2022-05-24

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 60 participants
• Primary outcome 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).
• Results posted on: 2022-05-24

Participant Flow

30 patients scheduled to undergo posterior spinal fusion 30 patients scheduled to undergo ventriculo-peritoneal (VP) shunt placement

Participant milestones

Measure	Administration of Vancomycin Administration of Vancomycin 15 mg/kg over 1 hour prior to surgical incision Administration of Vancomycin: Intravenous Vancomycin Administration
Overall Study STARTED	60
Overall Study COMPLETED	60
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Administration of Vancomycin n=59 Participants Administration of Vancomycin 15 mg/kg over 1 hour prior to surgical incision Administration of Vancomycin: Intravenous Vancomycin Administration
Age, Categorical <=18 years	57 Participants n=59 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=59 Participants
Age, Categorical >=65 years	0 Participants n=59 Participants
Age, Continuous	7.8 years STANDARD_DEVIATION 5.9 • n=59 Participants
Sex: Female, Male Female	37 Participants n=59 Participants
Sex: Female, Male Male	22 Participants n=59 Participants

PRIMARY outcome

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).

Population: One participant was excluded because the sample was lost.

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.

Outcome measures

Measure	Administration of Vancomycin n=59 Participants Administration of Vancomycin 15 mg/kg over 1 hour prior to surgical incision Administration of Vancomycin: Intravenous Vancomycin Administration
Pharmacokinetics Analysis: V˅c Typical value	2.56 L
Pharmacokinetics Analysis: V˅c w^2	1.14 L

PRIMARY outcome

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).

Population: One participant was excluded because the sample was lost.

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.

Outcome measures

Measure	Administration of Vancomycin n=59 Participants Administration of Vancomycin 15 mg/kg over 1 hour prior to surgical incision Administration of Vancomycin: Intravenous Vancomycin Administration
Pharmacokinetics Analysis: V˅2	5.30 L/35kg

PRIMARY outcome

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).

Population: One participant was excluded because the sample was lost.

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.

Outcome measures

Measure	Administration of Vancomycin n=59 Participants Administration of Vancomycin 15 mg/kg over 1 hour prior to surgical incision Administration of Vancomycin: Intravenous Vancomycin Administration
Pharmacokinetics Analysis: Q	0.12 L/min

PRIMARY outcome

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).

Population: One participant was excluded because the sample was lost.

Elimination clearance. This outcome measure was pre-specified to utilize advanced mathematical modeling for this assessment. No measure of central tendency is available.

Outcome measures

Measure	Administration of Vancomycin n=59 Participants Administration of Vancomycin 15 mg/kg over 1 hour prior to surgical incision Administration of Vancomycin: Intravenous Vancomycin Administration
Pharmacokinetics Analysis: Cle Typical value	0.09 L/min/1.73 m^2
Pharmacokinetics Analysis: Cle ꙍ^2 (Intersubject variability)	0.13 L/min/1.73 m^2

PRIMARY outcome

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).

Population: One participant was excluded because the sample was lost.

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.

Outcome measures

Measure	Administration of Vancomycin n=59 Participants Administration of Vancomycin 15 mg/kg over 1 hour prior to surgical incision Administration of Vancomycin: Intravenous Vancomycin Administration
Pharmacokinetics Analysis: sf˅V2	1.01 L/35kg

PRIMARY outcome

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).

Population: One participant was excluded because the sample was lost.

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.

Outcome measures

Measure	Administration of Vancomycin n=59 Participants Administration of Vancomycin 15 mg/kg over 1 hour prior to surgical incision Administration of Vancomycin: Intravenous Vancomycin Administration
Pharmacokinetics Analysis: sf˅Cle	1.69 L/min/1.73m^2

PRIMARY outcome

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)

Population: One participant was excluded because the sample was lost.

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.

Outcome measures

Measure	Administration of Vancomycin n=59 Participants Administration of Vancomycin 15 mg/kg over 1 hour prior to surgical incision Administration of Vancomycin: Intravenous Vancomycin Administration
Pharmacokinetics Analysis: K˅skin0 Typical value	3.6 min^-1
Pharmacokinetics Analysis: K˅skin0 ꙍ^2 (Intersubject variability)	2.0 min^-1

PRIMARY outcome

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)

Population: One participant was excluded because the sample was lost.

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.

Outcome measures

Measure	Administration of Vancomycin n=59 Participants Administration of Vancomycin 15 mg/kg over 1 hour prior to surgical incision Administration of Vancomycin: Intravenous Vancomycin Administration
Pharmacokinetics Analysis: PC Typical value	32.0 Coefficient
Pharmacokinetics Analysis: PC ꙍ^2 (Intersubject variability)	3.7 Coefficient

PRIMARY outcome

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)

Population: One participant was excluded because the sample was lost.

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.

Outcome measures

Measure	Administration of Vancomycin n=59 Participants Administration of Vancomycin 15 mg/kg over 1 hour prior to surgical incision Administration of Vancomycin: Intravenous Vancomycin Administration
Pharmacokinetics Analysis: δ ˅R-plasma	0.23 No unit of measure

PRIMARY outcome

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)

Population: One participant was excluded because the sample was lost.

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.

Outcome measures

Measure	Administration of Vancomycin n=59 Participants Administration of Vancomycin 15 mg/kg over 1 hour prior to surgical incision Administration of Vancomycin: Intravenous Vancomycin Administration
Pharmacokinetics Analysis: δ ˅A-skin	7.5 μg

Adverse Events

Administration of Vancomycin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Melissa Brooks-Peterson, MD

University of Colorado Denver | Anschutz

Phone: 30372411111

Email: clinicalresearchsupportcenter@ucdenver.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place