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Pharmacotherapy on CPB.

Pharmacokinetics and pharmacodynamics of drugs in neonates and children during Cardiopulmonary Bypass.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON26789
Enrollment
160
Registered
2012-08-14
Start date
2012-07-04
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

congenital heart disease pediatric population cardiopulmonary bypass Pharmacokinetics Pharmacodynamics

Interventions

Blood and Urine sampling.

Sponsors

Erasmus MC 's Gravendijkwal 230 Dept Anesthesiology/Thorax 3015 CE Rotterdam The Netherlands
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All pediatric patients 0-18 years old, stratified for age group, undergoing open heart surgery for congenital heart disease with the use of CPB are candidates for inclusion. The age-groups will be: 1. Neonates 0-30 days old; 2. Infants 30-365 days old; 3. Preschool children aged 1-4 years old; 4. School children aged 4-12 years old; 5. Adolescents aged 12-18 years old.

Exclusion criteria

Exclusion criteria: No informed consent.

Design outcomes

Primary

MeasureTime frame
1. Determination of population PK of midazolam, propofol, sufentanil, pancuronium, ranitidine, furosemide, enoximone and dobutamine in the pediatric population; 2. Determination of the relationship between the PK of the medication and clinical parameters as age, cyanotic or acyanotic cardiac defects, cardiopulmonary bypass system used, pump flow rate, liver and renal function and protein concentrations.

Secondary

MeasureTime frame
Determination of the relationship between PK and the clinical effect of aforementioned medication. DNA analysis will be performed to evaluate the influence of gene polymorphisms on the PD of anesthetic and analgesic medication.

Contacts

Public ContactL. Duininck

Erasmus University Medical Center PO Box 2040

e.duininck@erasmusmc.nl+31 10 70 32 150

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)