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Pharmacokinetics of Bolus Versus Continuous Cefazolin Infusion in Patients Undergoing Major Surgery

NCT02058979 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2016-10-26

No results posted yet for this study

Summary

Abstract The administration of an antibiotic preoperatively is an important intervention that helps to reduce the risk of post-operative health-care associated infections (HCAI). These include urinary tract, surgical site and blood stream infection. Based on the current Surgical Infection Prevention Project, (SCIP) recommendations, the choice of the antibiotic is based on the nature and site of the surgery and the presence of a β-lactam allergy (Table 1).

Currently, the antibiotic treatment for preventing surgical infections is administered as a single bolus an hour before surgery, and every four hours after the initial dose. This presents a concentration profile that has a high concentration after the bolus, but decays as the kidneys remove the antibiotics. In this present study, investigators would like to compare this traditional method of delivery to a constant infusion model that would sustain a constant level of antibiotics that is defined by the difference between the rate of infusion and rate of clearance.

Conditions

  • Plasma Concentration of Antibiotics

Interventions

DRUG

BOLUS INFUSION (Ancef)

Bolus Infusion of antibiotics

DRUG

CONTINUOUS INFUSION (Ancef)

Continuous Infusion of ANCEF with infusion pump

Sponsors & Collaborators

  • The University of Queensland

    collaborator OTHER

  • University of Virginia

    lead OTHER

Principal Investigators

  • BHIKEN NAIK, M.B. · University of Virginia

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02058979 on ClinicalTrials.gov