Pharmacokinetics of Post Operative Cefuroxime in Infants Undergoing Cardiac Surgery

NCT02850250 | Withdrawn DMC

• 1 other identifier: PHOXEY
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Cardiac Event

Keywords

Observational; pharmacokinetic; cardiac; Cefuroxime; Paediatric

Outcome Measures

Primary Outcomes (1)

• Plasma concentrations

  To measure plasma concentrations of Cefuroxime in this patient population

  12 months

Interventions

Cefuroxime DRUG

Patients selected and treated as per normal pathway of care. Drugs will be prescribed as per standard Alder Hey Policy at the doses defined in the hospital policy Cefuroxime 50mg/kg 8 hourly (12 hourly if less than 7 days of age, or undergoing peritoneal dialysis - maximum 1.5grams per dose)

Also known as: Ceftin

Eligibility Criteria

• Age: Up to 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children aged 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.

You may qualify if:

• 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.

You may not qualify if:

• No written informed consent
• Investigator's concerns
• Non English speaking
• No intra-arterial catheter

Sponsors & Collaborators

• Alder Hey Children's NHS Foundation Trust: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sampling on admission to PICU - then at 1 hour pre and post cefuroxime for 3 doses (8 hours apart)

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Cefuroxime; cefuroxime axetil

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2016
• First Posted: July 29, 2016
• Study Start: July 1, 2018
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: January 10, 2019

Record last verified: 2019-01