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Pharmacokinetics of Cefuroxime in Cardiac Surgery With Cardiopulmonary Bypass

NCT01228825 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 19

Last updated 2010-10-27

No results posted yet for this study

Summary

Infection, especially mediastinitis, is major complication in cardiac surgery. Considering that cardiopulmonary bypass (CPB) can alter kinetics of drugs, including antibiotics, the aim of this study was to evaluate the influence of cardiopulmonary bypass ( CPB) on plasma concentrations and pharmacokinetics of cefuroxime, administered prophylactically, in a 1.5g dose, followed by three bolus of 750mg every 6 hours, for 24 hours, in 19 patients undergoing coronary artery bypass graft (CABG) with CPB (CPB Group, n = 10), or without CPB (Off-Pump Group, n = 9); and assess whether the proposed dosing regimen is adequate to maintain plasma concentrations above 16 g/L (4 times the MIC) for the first 24 hours after the beginning of surgery.

Conditions

  • Cardiac Surgery

Sponsors & Collaborators

  • Santa Genoveva Hospital, Goiania GO, Brazil

    collaborator UNKNOWN

  • University of Sao Paulo

    lead OTHER

Principal Investigators

  • Fabiana AP Bosco Ferreira, MD · University of Sao Paulo

  • Maria Jose C Carmona, phD · University of Sao Paulo

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2008-04-30
Completion
2008-04-30

Countries

  • Brazil

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 NCT01228825 on ClinicalTrials.gov