Development of pharmacokinetic model for the target-concentration controlled infusion of cefoxitin used as a prophylactic antibiotic in surgical patients

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CRIS

Registry ID

KCT0004442

Enrollment

Registered

2019-11-15

Start date

2020-01-22

Completion date

Unknown

Last updated

2020-04-21

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

Conditions

None listed

Interventions

Drug : Cefoxitin (2 g) as a prophylactic antibiotic is given before skin incision

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? Patients over 20 to 80 years old ? Patients scheduled to undergo colorectal or rectal surgery at Asan Medical Center ? Patients with physical status of the American Society of Anesthesiologists, Class 1-3 ? Patients who weigh 40 kg or more ? Patients scheduled to receive cefoxitin as a prophylactic antibiotic ? Patients who have agreed in writing to voluntarily participate in this clinical study

Exclusion criteria

Exclusion criteria: ? Pregnant or breastfeeding women ? Patients with a history of hypersensitivity to cefoxitin ? Patients with a history of cefoxitin given within 3 days of the scheduled operation time ? Patients with hemoglobin <8 g / dl ? Estimated glomerular filtration rate measured before surgery <60 ml / min ? Patients who received other clinical trial drugs within 7 days of the surgery ? Patients deemed inappropriate by investigators

Design outcomes

Secondary

Measure	Time frame
adverse event	—

Primary

Measure	Time frame
pharmacokinetic parameter (volume of distribution, cleracne)	—

Countries

Korea, Republic of

Contacts

Public ContactByung-Moon Choi

Asan Medical Center

Outcome results