Steroid Metabolism in Obese and Non-Obese Pediatric Patients Hospitalized for Status Asthmaticus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in Prednisolone concentration levels as measured by ELISA
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
BMI > 95
Cohort 1: greater than or equal to 95%ile body mass index
干预措施: Methylprednisolone (Drug)
BMI < 95
Cohort 2: less than 95%ile body mass index
干预措施: Methylprednisolone (Drug)
结局指标
主要结局
Change in Prednisolone concentration levels as measured by ELISA
时间窗: 0, 24, 48, 72, 96 hours after methylprednisolone dosing
Prednisolone levels at steady state concentration
次要结局
- 11-beta-hydroxysteroid dehydrogenase as measured by ELISA(Up to 72 hours after methylprednisolone dosing)