Validation of the predictive performance of the pharmacokinetic model for cefoxitin used as a prophylactic antibiotic in surgical patients

External validation of the pharmacokinetic model for cefoxitin used as a prophylactic antibiotic in surgical patients

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CRIS

Registry ID

KCT0005456

Enrollment

Registered

2020-10-08

Start date

2020-11-01

Completion date

Unknown

Last updated

2020-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Procedure/Surgery : Cefoxitin as a prophylactic antibiotic is administered by plasma target-controlled infusion using pharmacokinetic modeling during surgery. The target plasma concentration of cefoxi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients over 20 to 80 years old 2. Patients who scheduled to undergo colorectal or rectal surgery at Asan Medical Center 3. Patients who scheduled to receive cefoxitin as a prophylactic antibiotic 4. Patients with the physical status of the American Society of Anesthesiologists, Class 1-3 5. Patients who weigh 40 kg or more 6. Patients who signed a written informed consent form

Exclusion criteria

Exclusion criteria: 1. Patients with a history of hypersensitivity to cefoxitin 2. Patients with a history of cefoxitin given within 3 days of the scheduled operation time 3. Patients with hemoglobin <8 g/dl 4. Estimated glomerular filtration rate measured before surgery <60 ml/min 5. Patients deemed inappropriate by investigators

Design outcomes

Primary

Measure	Time frame
Predicitve performance (bias, inaccuracy, wooble, divergence) of pharmacokinetic model	—

Secondary

Measure	Time frame
Infusion rate of target-controlled infusion pump	—

Countries

Korea, Republic of

Contacts

Public ContactKyung Mi Kim

Asan Medical Center

Outcome results