Pharmacokinetic Comparison of Cefazolin Redosing Strategy for Surgical Prophylaxis. Bolus Dose vs Continuous Infusion
Trial Snapshot
- Phase
- Phase 4
- Status
- Withdrawn
- Primary Endpoint
- Difference in Area Under Curve (AUC) of Cefazolin plasma concentration and minimum inhibitory concentration (MIC) in both treatment arms
Study Overview
Brief Summary
Patients undergoing an elective ventral hernia repair 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.
Detailed Description
Patients who will be undergoing elective ventral hernia repair 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 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 or 6 hours (whichever comes sooner)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age >18 years
- •Elective open Ventral hernia repair in CDC class one (clean) cases
- •Planned operative time greater than 4 Hours
- •Planned routine administration of cefazolin for pre-op prophylaxis
- •No history of MRSA
Exclusion Criteria
- •Patients unable to give informed consent
- •Allergy to cephalosporins
- •Pre-existing documented infection or ostomy (class II-IV wounds)
- •Received cefazolin within 24 hours before surgery
- •Creatinine clearance < 30 ml/min
- •Upstaging of wound class intra-op that results in the administration of additional antibiotics
Arms & Interventions
Continuous Infusion of Cefazolin
Subjects undergoing a ventral hernia repair in this arm of the study will receive the surgical prophylactic, cefazolin, in a continuous infusion
Intervention: Continuous infusion of Cefazolin (Procedure)
Bolus infusion of Cefazolin
Subjects undergoing a ventral hernia repair in this arm of the study will receive the surgical prophylactic, cefazolin, in a bolus infusion
Intervention: Bolus infusion of Cefazolin (Procedure)
Outcomes
Primary Outcomes
Difference in Area Under Curve (AUC) of Cefazolin plasma concentration and minimum inhibitory concentration (MIC) in both treatment arms
Time Frame: First four hours
After blood sample collection is completed samples will be analyzed for plasma concentrations of cefazolin. This concentration will be compared with the standard minimum inhibitory concentration of Cefazolin. It is expected that the difference between AUC and MIC in the continuous infusion group will be higher than the bolus infusion group during the first four hours of surgery.
Secondary Outcomes
- Total dose of cefazolin administered during the first 24 hours(24 hours after the beginning of surgery)
- Difference in AUC of plasma concentration between the two regimens for the entire duration of surgery(Duration of surgery)
- Total dose of cefazolin administered during the surgery(Duration of surgery)
Investigators
Kunal Karamchandani
Assistant Professor of Anesthesiology
Milton S. Hershey Medical Center