Continuous v Bolus Infusion of Cefazolin During Ventral Hernia Repair
Primary Purpose
Surgical Site Infections
Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Bolus infusion of Cefazolin
Continuous infusion of Cefazolin
Sponsored by
About this trial
This is an interventional prevention trial for Surgical Site Infections focused on measuring anesthesia, surgical antimicrobial prophylaxis, surgical site infections
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Bolus infusion of Cefazolin
Continuous Infusion of Cefazolin
Arm Description
Subjects undergoing a ventral hernia repair in this arm of the study will receive the surgical prophylactic, cefazolin, in a bolus infusion
Subjects undergoing a ventral hernia repair in this arm of the study will receive the surgical prophylactic, cefazolin, in a continuous infusion
Outcomes
Primary Outcome Measures
Difference in Area Under Curve (AUC) of Cefazolin plasma concentration and minimum inhibitory concentration (MIC) in both treatment arms
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
Difference in AUC of plasma concentration between the two regimens for the entire 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.
Total dose of cefazolin administered during the surgery
Total dose of cefazolin administered during the first 24 hours
Full Information
NCT ID
NCT02666365
First Posted
January 25, 2016
Last Updated
May 22, 2018
Sponsor
Milton S. Hershey Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02666365
Brief Title
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
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Investigator decided not to proceed.
Study Start Date
March 2018 (Anticipated)
Primary Completion Date
March 2019 (Anticipated)
Study Completion Date
June 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center
4. Oversight
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
Data Monitoring Committee
Yes
5. 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.
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infections
Keywords
anesthesia, surgical antimicrobial prophylaxis, surgical site infections
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bolus infusion of Cefazolin
Arm Type
Active Comparator
Arm Description
Subjects undergoing a ventral hernia repair in this arm of the study will receive the surgical prophylactic, cefazolin, in a bolus infusion
Arm Title
Continuous Infusion of Cefazolin
Arm Type
Active Comparator
Arm Description
Subjects undergoing a ventral hernia repair in this arm of the study will receive the surgical prophylactic, cefazolin, in a continuous infusion
Intervention Type
Procedure
Intervention Name(s)
Bolus infusion of Cefazolin
Other Intervention Name(s)
Bolus infusion
Intervention Description
Subjects in the bolus infusion arm of the study will receive bolus infusions of cefazolin throughout the surgical procedure
Intervention Type
Procedure
Intervention Name(s)
Continuous infusion of Cefazolin
Other Intervention Name(s)
Continuous infusion
Intervention Description
Subjects in the continuous infusion arm of the study will receive a continuous infusion of the cefazolin throughout the surgical procedure
Primary Outcome Measure Information:
Title
Difference in Area Under Curve (AUC) of Cefazolin plasma concentration and minimum inhibitory concentration (MIC) in both treatment arms
Description
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.
Time Frame
First four hours
Secondary Outcome Measure Information:
Title
Difference in AUC of plasma concentration between the two regimens for the entire duration of surgery
Description
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.
Time Frame
Duration of surgery
Title
Total dose of cefazolin administered during the surgery
Time Frame
Duration of surgery
Title
Total dose of cefazolin administered during the first 24 hours
Time Frame
24 hours after the beginning of surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kunal Karamchandani, MD
Organizational Affiliation
Milton S. Hershey Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Citation
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Continuous v Bolus Infusion of Cefazolin During Ventral Hernia Repair
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