Pharmacotherapy on CPB.
Recruiting
- Conditions
- congenital heart diseasepediatric populationcardiopulmonary bypassPharmacokineticsPharmacodynamics
- Registration Number
- NL-OMON26789
- Lead Sponsor
- Erasmus MC 's Gravendijkwal 230Dept Anesthesiology/Thorax3015 CE RotterdamThe Netherlands
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 160
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:
Exclusion Criteria
No informed consent.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Determination of population PK of midazolam, propofol, sufentanil, pancuronium, ranitidine, furosemide, enoximone and dobutamine in the pediatric population;<br /><br>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 Outcome Measures
Name Time Method 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.