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Completed

NCT Number: NCT04874610

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

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.

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Key information

Age range

2 year–20 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University Hospital

Durham, North Carolina, 27705, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 2 years and 20 years inclusive
  • Written informed consent provided by a parent or legal guardian
  • Admitted to Duke Children's Hospital for primary reason of asthma exacerbation (and treated with methylprednisolone)
  • BMI-percentile greater than 95th for obese subjects and BMI less than 95th percentile for non-obese subjects

Exclusion criteria

  • Patients with suspected liver failure, renal failure, sepsis, or cardiopulmonary instability deemed by the PI.
  • Receiving any extracorporeal life support including extracorporeal membrane oxygenation, ventricular assist devices, and renal replacement therapy at enrollment
  • Any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the participant or the quality of the data.

Treatment and study plan

methylprednisolone

Drug

Administration of methylprednisolone Prescribed per Standard of care

Primary outcomes

  1. 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 outcomes

  1. 11-beta-hydroxysteroid dehydrogenase as measured by ELISA

    Time frame: Up to 72 hours after methylprednisolone dosing

    11-beta-hydroxysteroid dehydrogenase levels

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 5, 2021
Registry last updated
Jul 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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