Obesity
Conditions
Brief summary
The purpose of this study is to evaluate cefoxitin pharmacokinetics in obese surgical patients.
Interventions
None listed
Sponsors
Washington University School of Medicine
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* BMI \<25 and \>40 * Scheduled for elective abdominal or pelvic surgery * Surgical plan for intraoperative cefoxitin prophylaxis * Able to provide informed consent
Exclusion criteria
* Allergy to Cefoxitin * Renal or Hepatic insufficiency
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cefoxitin Plasma Concentrations | 8 hours | Cefoxitin plasma concentrations |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cefoxitin Tissue Concentrations | 8 hours | Cefoxitin tissue concentrations |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Obese Patients Obese patients | 14 |
| Normal Weight Patients and Volunteers Normal weight patients and volunteers | 13 |
| Total | 27 |
Baseline characteristics
| Characteristic | Normal Weight Patients and Volunteers | Total | Obese Patients |
|---|---|---|---|
| Age, Continuous | 28 years STANDARD_DEVIATION 12 | 40 years STANDARD_DEVIATION 10 | 52 years STANDARD_DEVIATION 8 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 13 Participants | 27 Participants | 14 Participants |
| Sex: Female, Male Female | 7 Participants | 19 Participants | 12 Participants |
| Sex: Female, Male Male | 6 Participants | 8 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 13 |
| other Total, other adverse events | 0 / 14 | 0 / 13 |
| serious Total, serious adverse events | 0 / 14 | 0 / 13 |
Outcome results
Primary
Cefoxitin Plasma Concentrations
Cefoxitin plasma concentrations
Time frame: 8 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Obese Patients | Cefoxitin Plasma Concentrations | 89 (µg/mL) | Standard Deviation 20 |
| Normal Weight Patients and Volunteers | Cefoxitin Plasma Concentrations | 81 (µg/mL) | Standard Deviation 33 |
p-value: <0.05t-test, 2 sided
Secondary
Cefoxitin Tissue Concentrations
Cefoxitin tissue concentrations
Time frame: 8 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Obese Patients | Cefoxitin Tissue Concentrations | 8.8 (µg/mL) | Standard Deviation 6.6 |
| Normal Weight Patients and Volunteers | Cefoxitin Tissue Concentrations | 26 (µg/mL) | Standard Deviation 20 |