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

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: March 31, 2022

Detailed Description

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.

Interventions

  • Drug: Methylprednisolone
    • Administration of methylprednisolone Prescribed per Standard of care

Arms, Groups and Cohorts

  • BMI > 95
    • Cohort 1: greater than or equal to 95%ile body mass index
  • BMI < 95
    • Cohort 2: less than 95%ile body mass index

Clinical Trial Outcome Measures

Primary Measures

  • Change in Prednisolone concentration levels as measured by ELISA
    • Time Frame: 0, 24, 48, 72, 96 hours after methylprednisolone dosing
    • Prednisolone levels at steady state concentration

Secondary Measures

  • 11-beta-hydroxysteroid dehydrogenase as measured by ELISA
    • Time Frame: Up to 72 hours after methylprednisolone dosing
    • 11-beta-hydroxysteroid dehydrogenase levels

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 2 Years

Maximum Age: 20 Years

Investigator Details

  • Lead Sponsor
    • Duke University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Caitlin King, MD, Principal Investigator, Duke University

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.