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Antibiotic disposition in children undergoing heart surgery

Pharmacokinetics of prophylactic antibiotics in children undergoing heart surgery with cardiopulmonary bypass circuitry

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12615000809538
Enrollment
17
Registered
2015-08-05
Start date
2017-08-14
Completion date
2018-02-28
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Prophylactic antibiotic choice and dosing during paediatric cardiac surgery using cardiopulmonary bypass remains poorly defined. Cardiac surgery should be associated with an incidence of infection (superficial and deep) < 5%. This target is not reached in many centres. One contributing factor is a lack of understanding of antibiotic pharmacokinetics during support with extracorporeal circuits. Dosing may not achieve desired concentrations in the body. Children undergoing cardiac surgery will receive routine antibiotic prophylaxis. Blood concentrations will be monitored. Population pharmacokinetic modelling will be used to determine a dosing regimen to achieve desired target concentration.

Interventions

Pharmacokinetic analysis of antibiotic disposition in children undergoing cardiac surgery with cardiopulmonary bypass. Antibiotics (cephazolin, vancomycin) are given intravenously during the procedure only. The first dose is at induction of anaesthesia. A second dose is commonly given at the conclusion of cardiopulmonary bypass. They are not continued into the postoperative period. A dosing log will be kept.

Sponsors

Brian Anderson
Lead SponsorIndividual

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years
Healthy volunteers
No

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026