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

Completed

• Conditions: Pediatric Obesity; Asthma in Children
• Interventions: Drug: Methylprednisolone

• Registration Number: NCT04874610
• Lead Sponsor: Duke University

Brief Summary

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.

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.

Study Timeline

• Study First Submitted: 2021-05-03
• Study First Submitted QC: 2021-05-03
• Study First Posted: 2021-05-05
• Study Start: 2021-08-16
• Primary Completion: 2022-03-31
• Study Completion: 2022-03-31
• Status Verified: 2022-04
• Last Update Submitted: 2022-06-30
• Last Update Posted: 2022-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BMI > 95	Methylprednisolone	Cohort 1: greater than or equal to 95%ile body mass index
BMI < 95	Methylprednisolone	Cohort 2: less than 95%ile body mass index

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
11-beta-hydroxysteroid dehydrogenase as measured by ELISA	Up to 72 hours after methylprednisolone dosing	11-beta-hydroxysteroid dehydrogenase levels

Trial Locations

Locations (1)

Duke University Hospital; 🇺🇸 Durham, North Carolina, United States