Assessment of optimal perioperative antibiotic protection during coronary artery bypass surgery

Advanced antibiotic prophylaxis for optimal perioperative protection during coronary artery bypass grafting - Optimal antibiotic prophylaxis for CABG

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-000998-68-AT

Enrollment

Registered

2013-05-21

Start date

2013-07-02

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

antibiotic prophylaxis during cardiac surgery MedDRA version: 16.0 Level: LLT Classification code 10068176 Term: Coronary artery bypass graft System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 16.0 Level: PT Classification code 10011077 Term: Coronary artery bypass System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: CEFAZOLIN "Sandoz" 2 g - Trockenstechampulle Product Name: Cefazolin Sandoz 2 g-Trockenstechampulle Product Code: 1–20223 Pharmaceutical Form: Infusion INN or Proposed INN: CEFAZOLIN SODIU

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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. -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). ;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	—

Measure

Time frame

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. -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). ;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

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Secondary

Measure	Time frame
Secondary end point(s): - Measurements of subcutaneous tissue concentrations of cefazolin on the left and right pre-sternal subcutaneous tissue (surgically affected site). - Measurements of subcutaneous tissue concentrations of cefazolin on subcutaneous tissue on the thigh (surgically unaffected site). - Difference of tissue concentration of cefazolin between left and right pre-sternal subcutaneous tissue (surgically affected site) and on the thigh (surgically unaffected site). - 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	—

Measure

Time frame

Secondary end point(s): - Measurements of subcutaneous tissue concentrations of cefazolin on the left and right pre-sternal subcutaneous tissue (surgically affected site). - Measurements of subcutaneous tissue concentrations of cefazolin on subcutaneous tissue on the thigh (surgically unaffected site). - Difference of tissue concentration of cefazolin between left and right pre-sternal subcutaneous tissue (surgically affected site) and on the thigh (surgically unaffected site). - 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

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Countries

Austria

Contacts

Public ContactDoris Hutschala

Medizinische Universität Wien, Abteilung für Anästhesie und Intensivmedizin

doris.hutschala@meduniwien.ac.at00431404004107

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026