Pharmacokinetics of Post Operative Cefuroxime in Infants Undergoing Cardiac Surgery

• Status: Withdrawn
• Trial end date: 2019-10-01
• Target enrollment: 0
• Participant gender: All

Summary

• To evaluate plasma concentrations of Cefuroxime in this patient population

• To determine if certain pathophysiological and/or iatrogenic conditions alter the pharmacokinetics in this patient group.

• To develop a rational physiological population pharmacokinetic model that describes plasma concentrations of medications in these patients.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alder Hey Children's NHS Foundation Trust
• Treatments: Cefuroxime; Cefuroxime axetil

Criteria

Inclusion Criteria:

• Age from birth (>37 weeks gestation) to < 3 months

• Patients scheduled for congenital cardiac surgery and require cardiopulmonary bypass and intensive care admission post operatively in Alder Hey Children's Hospital

• Prescription of studied medications as per standard hospital policy.

• Intra-arterial catheter suitable for study sampling in situ.

• Informed consent by the parent or a legally authorised representative to participate in the study and to store specimens for immediate and future analysis.

Exclusion Criteria:

• No written informed consent

• Investigator's concerns

• Non English speaking

• No intra-arterial catheter