Determination of plasma levels of Cefoxitin during cardiac surgery on newborns, infants, and children under and over 40 kg weight

Phase 1

• Conditions: Antibiotic prophylaxis for surgical procedure using cardiopulmonary bypass in children with congenital heart disease.; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2016-004800-71-IT
• Lead Sponsor: Bambino Gesù Children's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-19
• Last Update Posted: 26 February 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified