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

Recruiting
Conditions
congenital heart disease (CHD)
10010394
10007510
Registration Number
NL-OMON39716
Lead Sponsor
Erasmus MC, Universitair Medisch Centrum Rotterdam
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
160
Inclusion Criteria

Pediatric patients undergoing open heart surgery for congenital heart disease with the use of CPB at the department of Cardiothoracic Surgery at the Erasmus Medical Centre.

Exclusion Criteria

No informed consent

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Determination of population pharmacokinetics of midazolam, propofol,<br /><br>sufentanil, pancuronium, ranitidine, furosemide, enoximone, and dobutamine in<br /><br>the pediatric population.<br /><br>Determination of the relationship between the pharmacokinetics of the<br /><br>medication and clinical parameters as age, cyanotic or acyanotic cardiac<br /><br>defects, cardiopulmonary bypass system used, pump flow rate, liver and renal<br /><br>function and protein concentrations.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Determination of the relationship between pharmacokinetics and the clinical<br /><br>effect of aforementioned medication. DNA analysis will be performed to evaluate<br /><br>the influence of gene polymorphisms on the pharmacodynamics of anesthetic and<br /><br>analgesic medication.<br /><br>Microcirculation measurements of the oromucosa before and after cardiopulmonary<br /><br>bypass. </p><br>
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