None listed
Conditions
Brief summary
This study will develop a pharmacokinetic model of isradipine, an oral treatment for acute hypertension in children, to facilitate accurate, age-specific dosing. We aim to clearly understand how isradipine is processed in children experiencing severe high blood pressure. With these data, we expect to prevent ‘under-doses’ that lead to delays, ineffective management, and disease progression requiring intensive care admissions. We also expect to avoid ‘over-doses’, leading to dangerously large blood pressure (BP) reduction and permanent damage to major organs. By identifying and quantifying critical factors that influence pharmacokinetic parameters in these children, we will develop a dosage regimen stratified by age and comorbidity. This approach will provide improved care to children over the current ‘trial-and-error’ approach with dosing regimens extrapolated from adult data in treating this at-risk population.
Interventions
Participant will be receiving isradipine AS PART OF standard care (i.e. regardless of their involvement in this study). participant will be observed until post 8 hours of subsequent isradipine dose (can be either 2nd or 3rd dose).
dosage and duration given as per current hospital guideline.
Starting dose 0.05-0.1 mg/kg (max 5 mg); dose may be repeated after one hour if required (usually dosing is 2-4 times per day) Titrate to effect, maximum daily dose 0.8 mg/kg/day (maximum 20 mg/day)
adher
Participant will be receiving isradipine AS PART OF standard care (i.e. regardless of their involvement in this study). participant will be observed until post 8 hours of subsequent isradipine dose (can be either 2nd or 3rd dose). dosage and duration given as per current hospital guideline. Starting dose 0.05-0.1 mg/kg (max 5 mg); dose may be repeated after one hour if required (usually dosing is 2-4 times per day) Titrate to effect, maximum daily dose 0.8 mg/kg/day (maximum 20 mg/day) adherence not applicable as isradipine dosing regimen is when required basis (i.e prn)
Sponsors
Child and Adolescent Health Service
Eligibility
Sex/Gender
All
Age
1 Months to 17 Years
Healthy volunteers
No
Inclusion criteria
1) Children, aged 1 month to 17 years of age prescribed isradipine to manage acute hypertension; 2) Written informed consent
Exclusion criteria
1) Hypersensitivity to isradipine or any component of the formulation; 2) previous dihydropyridine hypersensitivity
Outcome results
None listed