Steroid Metabolism in Obese and Non-Obese Pediatric Patients Hospitalized for Status Asthmaticus

Duke University15 enrolled

Overview

Single center, open-label, non-randomized study to assess the pharmacokinetic profile of methylprednisolone in healthy children 2-20 years of age admitted for asthma exacerbation.

This is a prospective study aiming to characterize the pharmacokinetics of methylprednisolone in obese and non-obese children hospitalized for asthma, and to build a metabolomic profile for each cohort. The primary hypothesis is that the obese cohort will have increased methylprednisolone clearance compared to the non-obese cohort. The secondary hypothesis is that the obese cohort will have decreased amounts of 11-β-hydroxysteroid dehydrogenase in the serum which will correlate to abnormalities in steroid clearance. The tertiary hypothesis is that the obese cohort will have increased levels of branched chain amino acids and inflammatory markers which will correlate to disease severity.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Pediatric Obesity Asthma in Children

Interventions

MethylprednisoloneDRUG

Administration of methylprednisolone Prescribed per Standard of care

Eligibility

Sex: ALLMin age: 2 YearsMax age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age between 2 years and 20 years inclusive 2. Written informed consent provided by a parent or legal guardian 3. Admitted to Duke Children's Hospital for primary reason of asthma exacerbation (and treated with methylprednisolone) 4. BMI-percentile greater than 95th for obese subjects and BMI less than 95th percentile for non-obese subjects Exclusion Criteria: 1. Patients with suspected liver failure, renal failure, sepsis, or cardiopulmonary instability deemed by the PI. 2. Receiving any extracorporeal life support including extracorporeal membrane oxygenation, ventricular assist devices, and renal replacement therapy at enrollment 3. Any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the participant or the quality of the data.

Locations (1)

Duke University Hospital

Durham, North Carolina, United States

Outcomes

Primary Outcomes

Change in Prednisolone concentration levels as measured by ELISA

Prednisolone levels at steady state concentration

Time frame: 0, 24, 48, 72, 96 hours after methylprednisolone dosing

Secondary Outcomes

11-beta-hydroxysteroid dehydrogenase as measured by ELISA

11-beta-hydroxysteroid dehydrogenase levels

Time frame: Up to 72 hours after methylprednisolone dosing

Data from ClinicalTrials.gov

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