This study is aimed at determining pharmacokinetics and pharmacodynamics of medications routinely used at the Erasmus Medical Centre in pediatric cardiac surgery during and after cardiopulmonary bypass. The goal is to be able to formulate evidence…
Source
Brief title
Condition
- Congenital cardiac disorders
- Cardiac and vascular disorders congenital
Synonym
Research involving
Sponsors and support
Intervention
No registrations found.
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Infants and children undergoing heart surgery with cardiopulmonary bypass (CPB)
are exposed to different anesthetics, adjuvants and cardiovascular medications.
Not much is known about the pharmacokinetics (PK) and pharmacodynamics (PD) of
medication we administer to infants and children on CPB and the first 36
postoperative hours. Most research has been done in the adult patient and
otherwise healthy children not undergoing cardiopulmonary bypass, but results
from those studies cannot just be extrapolated to the pediatric population with
congenital heart disease.
Study objective
This study is aimed at determining pharmacokinetics and pharmacodynamics of
medications routinely used at the Erasmus Medical Centre in pediatric cardiac
surgery during and after cardiopulmonary bypass. The goal is to be able to
formulate evidence based directions for dosing of medication on cardiopulmonary
bypass in the pediatric population.
The microcirculation of several organs can be altered because of the
cardiopulmonary bypass. These changes can influence the
pharmacokinetics.Therefore the microcirculation will be measured in the
oromucosa, which is easely accessible.
Study design
The study is a prospective observational study.
Study burden and risks
The research will be performed on children because results from studies on
adult patients cannot just be extrapolated to the pediatric population. Changes
in the pharmacokinetic properties of medication on bypass may be different in
children due to technical differences in bypass execution, developmental
differences in pharmacokinetic handling of medication in children of different
age groups and the hemodynamic changes depending on the nature of the
congenital abnormalities.
The patient will undergo routine anesthesia and cardiopulmonary bypass
according to Erasmus MC protocol with routinely performed monitoring and blood
sampling. Extra blood samples will be drawn from an already present arterial
line and the cardiopulmonary bypass system. This will equal a total of less
than 5 % of the circulating volume. Urine samples will be collected from a
routinely inserted urine catheter as well. Microcirculation measurements will
take place using a small probe. This should place minimal burden on the
patient.
's Gravendijkwal 230
Rotterdam 3015 CE
NL
's Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL37306.078.11 |
Other | NTR TC3579 |