Pharmacokinetics of Bolus Versus Continuous Cefazolin Infusion in Patients Undergoing Major Surgery

Completed · Not applicable

Conditions studied: Plasma Concentration of Antibiotics

In brief

Abstract The administration of an antibiotic preoperatively is an important intervention that helps to reduce the risk of post-operative health-care associated infections (HCAI). These include urinary tract, surgical site and blood stream infection. Based on the current Surgical Infection Prevention Project, (SCIP) recommendations, the choice of the antibiotic is based on the nature and site of the surgery and the presence of a β-lactam allergy (Table 1). Currently, the antibiotic treatment for preventing surgical infections is administered as a single bolus an hour before surgery, and every four hours after the initial dose. This presents a concentration profile that has a high concentration after the bolus, but decays as the kidneys remove the antibiotics. In this present study, investigators would like to compare this traditional method of delivery to a constant infusion model that would sustain a constant level of antibiotics that is defined by the difference between the rate of infusion and rate of clearance.

Key facts

Study ID

NCT02058979

Run by

University of Virginia

People needed

20

Starts

2014-11-01

Expected to finish

2016-06-01

Last updated by the study team

2016-10-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age > 18 years
• Elective abdominal and orthopedic surgery
• A patent arterial line
• A patent IV line
• Must be able to read and speak English

You may not qualify if…

• Subjects unable to give informed consent.
• Allergy to cefazolin
• Cognitively Impared
• Prisoners
• Pregnant females (self reported)
• History of coagulopathy
• Subjects presenting for emergency abdominal surgery
• Creatinine clearance < 30 ml/min
• Received cefazolin within 72 hours prior to surgery

Where it is running

• University of Virginia — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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