Antibiotic prophylaxis for surgical procedure using cardiopulmonary bypass in children with congenital heart disease.
Conditions
Interventions
Trade Name: Mefoxin
Product Name: Cefoxitina
Pharmaceutical Form: Powder for solution for infusion
Sponsors
Bambino Gesù Children's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Elective cardiac surgery schedule with the planned application of CPB. -Parents of elegible children, or their legal representative, able to consent and comply with protocol requirements. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Urgent or emergent surgery -Antibiotic therapy (any) administered before surgery -Patients receiving, before surgery, any other form of extracorporeal treatment (i.e ECMO, CRRT) -Previous renal or hepatic dysfunction requiring need for antibiotic posology modification. -Surgery requiring antibiotic prophylaxis with different drug combinations (i.e vancomycin and gentamycin) -ELBW neonates.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study the pharmacokinetic profile of cefoxitin administered, as antibiotic prophylaxis to children undergoing elective CPB. ;Secondary Objective: •To evaluate if a significant difference in blood levels will occur in the four predetermined patients’ categories. •To evaluate the role of hemodilution during CPB on studied antibiotic’s serum concentration •To verify the incidence of post-operative infections in the studied population with particular attention to sensitive bacteria •To evaluate the impact of ultrafiltration in studied antibiotic’s clearance •To evaluate safety of the administered antibiotic ;Primary end point(s): Quantification of cefoxitin blood levels, through samples collected after anesthesia induction. Blood draws are to be taken at skin incision (approximately one hour after cefoxitin bolus), 15 minutes after CPB start (CPB1), at the end of CPB (CPB2) and at the end of surgery. ;Timepoint(s) of evaluation of this end point: The day of prophylactic therapy coincides with the day of the surgical procedure | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To compare peak and through values in neonates, infants, children weighting less than 40 kg and children weighting more than 40 kg To evaluate the impact of CPB volume with respect of patients’ body weight, including the amount of fluids (crystalloids, colloids and hemoderivatives) administered intraoperatively to studied patients, on the enrolled patients The incidence of post-operative infections in the studied population with particular attention to sensitive bacteria (including methicillin resistant staphylococcus aureus) will be recorded throughout patients’ PCICU admission. The concentration of cefoxitin in the ultrafiltrate (UF) and their total removal will be evaluated at the end of CPB (UF1) from the total UF volume. The UF volume will be specifically recorded. Antibiotic’s sieving coefficient (SC) will be calculated as UF1/[(CPB1+CPB2)/2]. Antibiotic clearance will be calculated as SC*UF rate (ml/min).Evaluation of adverse events (serious and non-serious) and adverse drug reactions throughout the duration of trial by assessment of physical examination, vital signs, 12-lead electrocardiogram. Serious and non-serious adverse events will be collected intra-operatively.;Timepoint(s) of evaluation of this end point: 1.The day of the prophylactic treatment coincident with the surgical procedure (from 1 hour before surgical incision); 2. Each visit postoperatively; 3. Last day coinciding with the discharge from the cardio surgical intensive care | — |
Countries
Italy
Contacts
Public ContactChiara Mennini
Bambino Gesù Children's Hospital
Outcome results
None listed