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

Sponsor

Duke University (Other)

Overall Status

Completed

CT.gov ID

NCT04874610

Collaborator

(none)

Enrollment

Location

7.5

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pediatric Obesity Asthma in Children	Drug: Methylprednisolone

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 Design

Study Type:

Observational

Actual Enrollment :

15 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Aug 16, 2021

Actual Primary Completion Date :

Mar 31, 2022

Actual Study Completion Date :

Mar 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
BMI > 95 Cohort 1: greater than or equal to 95%ile body mass index	Drug: Methylprednisolone Administration of methylprednisolone Prescribed per Standard of care
BMI < 95 Cohort 2: less than 95%ile body mass index	Drug: Methylprednisolone Administration of methylprednisolone Prescribed per Standard of care

Arm

Intervention/Treatment

BMI > 95

Cohort 1: greater than or equal to 95%ile body mass index

Drug: Methylprednisolone

Administration of methylprednisolone Prescribed per Standard of care

BMI < 95

Cohort 2: less than 95%ile body mass index

Drug: Methylprednisolone

Administration of methylprednisolone Prescribed per Standard of care

Outcome Measures

Primary Outcome Measures

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

11-beta-hydroxysteroid dehydrogenase as measured by ELISA [Up to 72 hours after methylprednisolone dosing]
11-beta-hydroxysteroid dehydrogenase levels

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 20 Years

Sexes Eligible for Study:

All

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.