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Continuous v Bolus Infusion of Cefazolin During Whipple Procedure

2016-01-28 16:53:24 | BioPortfolio

Summary

Patients undergoing an elective whipple procedure will be randomly assigned to receive either bolus infusion or continuous infusion of the cefazolin as the prophylactic antibiotic. The blood concentrations of unbound cefazolin would be measured in their blood samples and the levels compared within the two groups with respect to their minimal inhibitory concentration (MIC) value.

Description

Patients who will be undergoing elective Whipple procedures will be potential candidates for this study. Once identified, the surgical team will approach the participant for consent and inclusion in the study. On the day of surgery, the subjects will be assigned to either the Bolus Group (CB) or Continuous Infusion Group (CI) according to a randomly generated assignment procedure. During the Whipple procedure, the dose of prophylactic Cefazolin will be given an hour before surgery and will be administered in accordance to group assignment. Subjects in the CB will receive bolus infusions of Cefazolin every 4 hours till the end of surgery. Subjects in the CI group will receive an initial bolus injection of Cefazolin followed by a continuous infusion till the closure of skin incision. Blood samples will be taken during surgery at t=0, 15, 30 and 60 minutes and every hour following till the end of surgery.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Conditions

Surgical Site Infections

Intervention

Bolus infusion of Cefazolin, Continuous infusion of Cefazolin

Status

Not yet recruiting

Source

Milton S. Hershey Medical Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-01-28T16:53:24-0500

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