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

Pediatric Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04874610
• Other study ID #: Pro00108152
• Status: Completed
• Start date: August 16, 2021
• Est. completion date: March 31, 2022

Study information

• Verified date: April 2022
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Gender: All
• Age group: 2 Years to 20 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma in Children
• Pediatric Obesity
• Status Asthmaticus

Intervention

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

Locations

Country	Name	City	State
United States	Duke University Hospital	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Prednisolone concentration levels as measured by ELISA	Prednisolone levels at steady state concentration	0, 24, 48, 72, 96 hours after methylprednisolone dosing
Secondary	11-beta-hydroxysteroid dehydrogenase as measured by ELISA	11-beta-hydroxysteroid dehydrogenase levels	Up to 72 hours after methylprednisolone dosing