EUCTR2016-004800-71-ITActive, not recruitingPhase 1
Determination of intraoperative levels of Cefoxitin during cardiac surgery requiring cardiopulmonary bypass in neonates, infants, children below, and above 40 kg.
Bambino Gesù Children's Hospital0 sites40 target enrollmentStarted: December 19, 2016Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 40
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •-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.
Investigators
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