Clinical trial NCT02666365: Continuous v Bolus Infusion of Cefazolin During Ventral Hernia Repair
Official title: Pharmacokinetic Comparison of Cefazolin Redosing Strategy for Surgical Prophylaxis. Bolus Dose vs Continuous Infusion
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Surgical Site Infections
Keywords: anesthesia
surgical antimicrobial prophylaxis
surgical site infections
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2016-01-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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)

Eligibility criteria: 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

Primary outcomes:
measure: Difference in Area Under Curve (AUC) of Cefazolin plasma concentration and minimum inhibitory concentration (MIC) in both treatment arms
timeFrame: First four hours
Secondary outcomes:
measure: Difference in AUC of plasma concentration between the two regimens for the entire duration of surgery
timeFrame: Duration of surgery
measure: Total dose of cefazolin administered during the surgery
timeFrame: Duration of surgery
measure: Total dose of cefazolin administered during the first 24 hours
timeFrame: 24 hours after the beginning of surgery
Other outcomes:
Locations:
Study officials:
affiliation: Milton S. Hershey Medical Center
name: Kunal Karamchandani, MD
role: PRINCIPAL_INVESTIGATOR
References:
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