Pharmacometric Modeling of a Hospital Preparation
ConditionHypertensive Patients
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-15
SponsorUniversity Hospital, Rouen
About this trial
Pediatric prescribers are very often faced with a lack of suitable therapies, particularly oral ones. This represents a major public health problem and necessitates adjustments to dosage or pharmaceutical form using medications marketed for adults, some of which contain excipients that may be harmful to children. This creates risks of dilution errors, administration errors, and the occurrence of adverse effects. Hospital pharmacy technicians are called upon daily to provide appropriate treatment for children. However, although this activity is authorized (Public Health Code, Good Preparation Practices), pharmacokinetic/pharmacodynamic studies on these preparations are only exceptionally carried out. Indeed, only stability studies are required to determine the expiration date of the preparation. Thus, prescribers are left without the necessary information to choose the dosage and administration schedule. Pediatric dosages are extrapolated from those for adults without any certainty of the treatment's effectiveness.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 1 to 15 years, male or female.
Patients followed in pediatric hematology-oncology.
Patients with a central venous catheter as part of their initial care and available for blood sampling.
Patients with a prescription for oral nicardipine (oral solution) whose formulation and/or dosage is/are not compatible with the commercial form of Loxen® 20 mg, requiring preparation.
Disqualifiers
Patient n'ayant pas un schéma d'administration toutes les 8 heures.
Hypersensibilité à la substance active.
Antécédent d'allergie à l'un des excipients (polysorbate 80, hypromellose, saccharine sodique, sorbate de potassium, acide citrique, citrate de sodium, saccharose).
Refus de participation de l'enfant, des parents ou du représentant légal.
Trial population
Children in pediatric hematology-oncology requiring nicardipine administration as part of their standard care whether or not they are nicardipine-naïve (switching from the intravenous form used for hypertensive emergencies to the oral form, or patients already receiving hospital-prepared nicardipine oral solution at 2 mg/mL)
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Evaluation of the pharmacokinetic parameters of an oral formulation of nicardipine hydrochloride
Other interventionThese pharmacokinetic parameters aim to optimize the use of this preparation in the management of pediatric hypertension. The pharmacokinetic parameters are: the area under the curve (AUC), the apparent volume of distribution (Vd/F), the apparent clearance (Cl/F), the maximum concentration (Cmax), the time to reach this concentration (Tmax), the elimination constant (ke), the elimination half-life (t1/2), the apparent intercompartmental clearance (Q/F), the apparent central volume (Vc/F), and the apparent peripheral volume (Vp/F). This kinetic profile will be obtained using Monolix® software modeling with the results of validated blood sampling methods. A small blood volume (1 mL) is required for these samples, which are taken from children who previously had a central venous catheter inserted.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Pharmacokinetic parameters in the target population of an oral formulation of nicardipine hydrochloride prepared by the pharmaceutical technology unit of the pharmacy at the Rouen University Hospital (Area Under the Curve (AUC)).
This kinetic profile will be obtained through modeling using Monolix® software and the results of validated assays of the samples. A small blood volume (1 mL) is required for these samples, which are taken from children who previously had a central venous catheter inserted.
Time frame
24 hours2
Pharmacokinetic parameters in the target population of an oral formulation of nicardipine hydrochloride prepared by the pharmaceutical technology unit of the pharmacy at the Rouen University Hospital (apparent distribution volume (Vd/F)).
This kinetic profile will be obtained through modeling using Monolix® software and the results of validated assays of the samples. A small blood volume (1 mL) is required for these samples, which are taken from children who previously had a central venous catheter inserted.
Time frame
24 hours3
Pharmacokinetic parameters in the target population of an oral formulation of nicardipine hydrochloride prepared by the pharmaceutical technology unit of the pharmacy at the Rouen University Hospital (apparent clearance (Cl/F)).
This kinetic profile will be obtained through modeling using Monolix® software and the results of validated assays of the samples. A small blood volume (1 mL) is required for these samples, which are taken from children who previously had a central venous catheter inserted.
Time frame
24 hours4
Pharmacokinetic parameters in the target population of an oral formulation of nicardipine hydrochloride prepared by the pharmaceutical technology unit of the pharmacy at the Rouen University Hospital (maximum concentration (Cmax)).
This kinetic profile will be obtained through modeling using Monolix® software and the results of validated assays of the samples. A small blood volume (1 mL) is required for these samples, which are taken from children who previously had a central venous catheter inserted.
Time frame
24 hoursSecondary outcomes
1
Describe the distribution of the residual concentration at 24 hours
Evaluate the determination of the residual concentration of nicardipine hydrochloride at 24 hours.
Time frame
24 hours2
Demographic parameters of the studied population: sex
Evaluate the demographic parameters of the studied population: sex
Time frame
24 hours3
Demographic parameters of the studied population: age
Evaluate the demographic parameters of the studied population: age
Time frame
24 hours4
Demographic parameters of the studied population: weight .
Evaluate the demographic parameters of the studied population: weight.
Time frame
24 hoursSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: