Phase 4
N=60
Pharmacokinetics of Preoperative Vancomycin
Surgical Site Infection · Vancomycin
Bottom Line
View on ClinicalTrials.gov: NCT03453684 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
May 2022
Primary outcome: Primary: Pharmacokinetics Analysis: V˅c — 2.56; 1.14 L
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Administration of Vancomycin (Drug)
- Age
- Pediatric, Adult · 0+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics Analysis: V˅c |
2.56; 1.14 | — |
| PRIMARY Pharmacokinetics Analysis: V˅2 |
5.30 | — |
| PRIMARY Pharmacokinetics Analysis: Q |
0.12 | — |
| PRIMARY Pharmacokinetics Analysis: Cle |
0.09; 0.13 | — |
| PRIMARY Pharmacokinetics Analysis: sf˅V2 |
1.01 | — |
| PRIMARY Pharmacokinetics Analysis: sf˅Cle |
1.69 | — |
| PRIMARY Pharmacokinetics Analysis: K˅skin0 |
3.6; 2.0 | — |
| PRIMARY Pharmacokinetics Analysis: PC |
32.0; 3.7 | — |
| PRIMARY Pharmacokinetics Analysis: δ ˅R-plasma |
0.23 | — |
| PRIMARY Pharmacokinetics Analysis: δ ˅A-skin |
7.5 | — |
Summary
A study of plasma and tissue vancomycin pharmacokinetics in pediatric surgical patients.
Eligibility Criteria
Inclusion Criteria
- Neurosurgery patients between the ages of 31 days up to 18 years
- Receiving a single dose of vancomycin administered prior to surgery for cerebrospinal fluid (CSF) shunt placement or revision.
- Orthopedic surgical patients between the ages of 31 days up to 18 years
- Receiving a single dose of vancomycin administered prior to surgery for definitive spinal fusion.
Exclusion Criteria
- Patients already receiving vancomycin for treatment of an active infection,
- Patients who have a Creatinine ≥1.2,
- Patients who's creatinine clearance less than 50,
- Known chronic renal failure and are on dialysis,
- Patients with a known allergy to vancomycin, not including Red Man Syndrome.
Data sourced from ClinicalTrials.gov (NCT03453684). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.