Antibiotic disposition in children undergoing heart surgery

Not Applicable

Recruiting

• Conditions: children with heart disease; Cardiac surgery related infection; Infection - Studies of infection and infectious agents; Cardiovascular - Other cardiovascular diseases; Surgery - Other surgery

• Registration Number: ACTRN12615000809538
• Lead Sponsor: Brian Anderson

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-08-05
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

children with heart disease presenting for surgery that requires extracorporeal circuits

Exclusion Criteria

refusal by parent/caregiver or child for consent
known allergy to antibiotic

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Characterise antibiotic disposition in children undergoing cardiopulmonary bypass or on extracorporeal circuits.<br>Blood assays taken after drug administration will be used for a pharmacokinetic population analysis using mixed effects models. Covariate effects (age, size, renal function, surgical type, bypass duration, temperature) will be assessed in order to decrease population parameter variability.[Approx 15 blood samples for assay from each individual will be taken over the duration of surgery from anaesthesia induction and into a 12 h postoperative period. Specific time points are not used for this type of analysis, but rather windows of time e.g. early samples assist determination of V; late samples (3 half lives) help determine CL. Samples will be required after interventions (e.g bypass initiation). Optimal design simulation will be used to determine the best windows for sampling]

Secondary Outcome Measures

Name	Time	Method
The use of simulation using computer modelling to predict therapeutic blood concentrations in a typical individual[This simulation analysis will be performed once data for primary endpoint analysis is complete. We anticipate 6 months after PK analysis is complete ]