Assessment of optimal perioperative antibiotic protection during coronary artery bypass surgery

• Conditions: antibiotic prophylaxis during cardiac surgery; MedDRA version: 16.0Level: LLTClassification code 10068176Term: Coronary artery bypass graftSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 16.0Level: PTClassification code 10011077Term: Coronary artery bypassSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2013-000998-68-AT
• Lead Sponsor: Medizinische Universität Wien, Abteilung für Anästhesie und Intensivmedizin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-21
• Last Update Posted: 29 July 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

-Written informed consent.
-Planned coronary artery bypass grafting with unilateral internal mammary artery bypass.
-Planned use of cardiopulmonary bypass.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

-Inability to give informed consent.
-Know allergy to cephalosporin’s or penicillin.
-Re-operation.
-Preoperative renal failure.
-Chronic severe renal insufficiency including hemodialysis.
-BMI > 35.
-Long standing diabetes mellitus (> 7 years) and insulin-dependent diabetes mellitus.
-Ejection fraction <20% measured with transthoracic echocardiography.
-Childbearing potential

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: -To evaluate subcutaneous tissue levels of cefazolin in surgically affected areas left and right of the sternal midline.;Secondary Objective: -To compare tissue levels of cefazolin in surgically affected areas (left and right of the sternal midline) to surgically unaffected tissue on the thigh.<br>-To compare subcutaneous cefazolin levels after advanced dosage of perioperative prophylaxis (4g two hours before cardiac surgery + 6 g perioperatively) with tissue levels after standard cefazolin prophylaxis (6g perioperatively) (data from our previous trial).<br><br>;Primary end point(s): -Measurements of baseline subcutaneous cefazolin concentrations after an advanced antibiotic dosage prior to cardiac surgery.;Timepoint(s) of evaluation of this end point: during surgery and postoperatively for 12 hours after skin incision

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): -Measurements of subcutaneous tissue concentrations of cefazolin on the left and right pre-sternal subcutaneous tissue (surgically affected site).<br>-Measurements of subcutaneous tissue concentrations of cefazolin on subcutaneous tissue on the thigh (surgically unaffected site).<br>-Difference of tissue concentration of cefazolin between left and right pre-sternal subcutaneous tissue (surgically affected site) and on the thigh (surgically unaffected site).<br>-Comparison of target tissue concentration to plasma concentration at different time points prior to, during and after cardiopulmonary bypass.;Timepoint(s) of evaluation of this end point: during surgery and postoperatively for 12 hours after skin incision