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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CRIS

Registry ID

KCT0005963

Enrollment

Registered

2021-03-05

Start date

2021-03-02

Completion date

Unknown

Last updated

2021-03-22

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

Conditions

None listed

Interventions

Drug : Cefazolin (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 stomach or breast surgery at Asan Medical Center E rosette ? Patients with the physical status of the American Society of Anesthesiologists, Class 1-3 ? Patients who weigh 40 kg or more ? Patients scheduled to receive cefazolin 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 cefazolin ? Patients with a history of cefazolin 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

Primary

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

Secondary

Measure	Time frame
adverse events	—

Countries

Korea, Republic of

Contacts

Public ContactKyung Mi Kim

Asan Medical Center

Outcome results