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The aim of this study will be to evaluate vancomycin and cefoxitin blood levels during elective cardiopulmonary bypass (CPB) surgery in four pre-determined pediatric strata: neonates, infants, children weighting less than 40 kg and children weighting more than 40 kg.
Few data are available in current literature about pharmacokinetics (PK) of antibiotics administered as surgical prophylaxis to children scheduled for cardiac surgery with CPB. In particular, vancomycin PK during CPB has been studied only in small case series, whereas no specific study has been conducted, so far, in the specific setting of children receiving cefoxitin during CPB.
CPB affects patients' volemia and drugs PK is eventually altered. On the other side during and after surgery for heart defects, many risk factors may decrease renal and hepatic clearance, including altered renal perfusion, use of vasoactive agents, and use of concomitant nephrotoxic medications.
Primary Objective of the study will be:
• To study the pharmacokinetic profile of vancomycin and cefoxitin administered, as antibiotic prophylaxis to children undergoing elective CPB.
Secondary Objectives will be:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vancomycin and cefoxitin pharmacokinetics | This is surgical prophylaxis and cefoxitin/vancomycin have to be administered to each patient of the study, before surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vancomycin pharmacokinetics | Other | vancomycin serial plasmatic and ultrafiltrate samples in order to assess plasmatic and ultrafiltrate drug concentrations |
|
| Measure | Description | Time Frame |
|---|---|---|
| vancomycin and cefoxitin concentration change in serial plasmatic samples | a 4-points pharmacokinetic curve per each antibiotic will be generated by serial average plasmatic vancomycin and cefoxitin concentration assessments. | samples will be withdrawn: at skin incision, 15 minutes after CPB start (CPB1), at the end of CPB (CPB2), at end of surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| differences between pre-determined subgroups (neonates, infants, children weighting less than 40 kg and children weighting more than 40 kg) in plasmatic vancomycin and cefoxitin levels change at each time point | samples will be withdrawn: at skin incision, 15 minutes after CPB start (CPB1), at the end of CPB (CPB2). | |
| vancomycin and cefoxitin clearance by ultrafiltration |
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Inclusion Criteria:
Exclusion Criteria:
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Children undergoing cardiac surgery requiring cardiopulmonary bypass and antibiotic prophylaxis with vancomycin and cefoxitin
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| Name | Affiliation | Role |
|---|---|---|
| zaccaria ricci, MD | Bambino Gesù Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Terapia Intenisva Cardiochirurgica | Roma | 00165 | Italy |
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| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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| cefoxitin pharmacokinetics | Other | cefoxitin serial plasmatic and ultrafiltrate samples in order to assess plasmatic and ultrafiltrate drug concentrations |
|
The clearance of vancomycin and cefoxitin in the ultrafiltrate (UF) will be evaluated. Antibiotics' sieving coefficient (SC) will be calculated from antibiotics concentrations at the following time points: UF1/[(CPB1+CPB2)/2]. Antibiotics clearance will be calculated as SC*UF rate (ml/min) |
| Ultrafiltrate sample will be withdrawn at the end of CPB (UF1) |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |