Continuous v Bolus Infusion of Cefazolin During Ventral Hernia Repair

May 22, 2018 updated by: Kunal Karamchandani, Milton S. Hershey Medical Center

Pharmacokinetic Comparison of Cefazolin Redosing Strategy for Surgical Prophylaxis. Bolus Dose vs Continuous Infusion

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
First four hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in AUC of plasma concentration between the two regimens for the entire duration of surgery
Time Frame: 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.
Duration of surgery
Total dose of cefazolin administered during the surgery
Time Frame: Duration of surgery
Duration of surgery
Total dose of cefazolin administered during the first 24 hours
Time Frame: 24 hours after the beginning of surgery
24 hours after the beginning of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milton S. Hershey Medical Center

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

March 1, 2018

Primary Completion (ANTICIPATED)

March 1, 2019

Study Completion (ANTICIPATED)

June 1, 2019

Study Registration Dates

First Submitted

January 25, 2016

First Submitted That Met QC Criteria

January 25, 2016

First Posted (ESTIMATE)

January 28, 2016

Study Record Updates

Last Update Posted (ACTUAL)

May 24, 2018

Last Update Submitted That Met QC Criteria

May 22, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00003845

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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