E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
antibiotic prophylaxis during cardiac surgery |
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E.1.1.1 | Medical condition in easily understood language |
antibiotic prophylaxis during cardiac surgery |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10068176 |
E.1.2 | Term | Coronary artery bypass graft |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10011077 |
E.1.2 | Term | Coronary artery bypass |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
- To evaluate subcutaneous tissue levels of cefazolin in surgically affected areas left and right of the sternal midline. |
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E.2.2 | Secondary objectives of the trial |
- 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).
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Written informed consent. - Planned coronary artery bypass grafting with unilateral internal mammary artery bypass. - Planned use of cardiopulmonary bypass.
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
- Measurements of baseline subcutaneous cefazolin concentrations after an advanced antibiotic dosage prior to cardiac surgery. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
during surgery and postoperatively for 12 hours after skin incision |
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E.5.2 | 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. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
during surgery and postoperatively for 12 hours after skin incision |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |