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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON39716

Enrollment

160

Registered

2011-12-23

Start date

2012-07-04

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

congenital heart disease (CHD)

Interventions

None listed

Eligibility

Age

2 Years to 17 Years

Inclusion criteria

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

Exclusion criteria: No informed consent

Design outcomes

Primary

Measure	Time frame
Determination of population pharmacokinetics of midazolam, propofol, sufentanil, pancuronium, ranitidine, furosemide, enoximone, and dobutamine in the pediatric population. Determination of the relationship between the pharmacokinetics 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.	—

Measure

Time frame

Determination of population pharmacokinetics of midazolam, propofol, sufentanil, pancuronium, ranitidine, furosemide, enoximone, and dobutamine in the pediatric population. Determination of the relationship between the pharmacokinetics 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

Measure	Time frame
Determination of the relationship between pharmacokinetics and the clinical effect of aforementioned medication. DNA analysis will be performed to evaluate the influence of gene polymorphisms on the pharmacodynamics of anesthetic and analgesic medication. Microcirculation measurements of the oromucosa before and after cardiopulmonary bypass.	—

Countries

Netherlands

Outcome results