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Continuous v Bolus Infusion of Cefazolin During Ventral Hernia Repair

Sponsor
Milton S. Hershey Medical Center (Other)
Overall Status
Withdrawn
CT.gov ID
NCT02666365
Collaborator
(none)
0
Enrollment
2
Arms
15
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Bolus infusion of Cefazolin
  • Procedure: Continuous infusion of Cefazolin
 Phase 4

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
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Pharmacokinetic Comparison of Cefazolin Redosing Strategy for Surgical Prophylaxis. Bolus Dose vs Continuous Infusion
Anticipated Study Start Date :
Mar 1, 2018
Anticipated Primary Completion Date :
Mar 1, 2019
Anticipated Study Completion Date :
Jun 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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

Procedure: Bolus infusion of Cefazolin
Subjects in the bolus infusion arm of the study will receive bolus infusions of cefazolin throughout the surgical procedure
Other Names:
  • Bolus infusion

    		•
    Active Comparator: 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

    Procedure: Continuous infusion of Cefazolin
    Subjects in the continuous infusion arm of the study will receive a continuous infusion of the cefazolin throughout the surgical procedure
    Other Names:
  • Continuous infusion

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Difference in Area Under Curve (AUC) of Cefazolin plasma concentration and minimum inhibitory concentration (MIC) in both treatment arms [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 Outcome Measures

    1. Difference in AUC of plasma concentration between the two regimens for the entire duration of surgery [Duration of surgery]

      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 for the entire duration of surgery.

    2. Total dose of cefazolin administered during the surgery [Duration of surgery]

    3. Total dose of cefazolin administered during the first 24 hours [24 hours after the beginning of surgery]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Milton S. Hershey Medical Center

    Investigators

    • Principal Investigator: Kunal Karamchandani, MD, Milton S. Hershey Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Kunal Karamchandani, Assistant Professor of Anesthesiology, Milton S. Hershey Medical Center
    ClinicalTrials.gov Identifier:
    NCT02666365
    Other Study ID Numbers:
    • STUDY00003845
    First Posted:
    Jan 28, 2016
    Last Update Posted:
    May 24, 2018
    Last Verified:
    May 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Kunal Karamchandani, Assistant Professor of Anesthesiology, Milton S. Hershey Medical Center
    anesthesia
    surgical antimicrobial prophylaxis
    surgical site infections
    Additional relevant MeSH terms:
    Surgical Wound Infection
    Cefazolin

    Study Results

    No Results Posted as of May 24, 2018