NL-OMON26131已完成不适用
Pediatric Microdosing midazolam: elucidating age-related changes in oral drug absorption
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Age 0 to 6 years inclusive - At least 36 weeks of post conceptual age or bodyweight >2,5kg - Intravenous or intra-arterial access for blood sampling in place - Receiving midazolam IV - Parental informed consent
排除标准
- •Anticipated death in 48 hours - No informed consent - ECMO treatment - Circulatory failure: receiving more than 1 vasopressor or increase of vasopressor drug dose in the last 6 hours. - Chronic liver cirrhosis or chronic renal failure - Renal disorders: Estimated risk for kidney injury or failure at least ‘risk for renal dysfunction’ according to pRIFLE criteria - Hepatic failure: >2SD in age appropriate liver enzyme measurement (ASAT and ALAT) - Gastrointestinal disorderse - Use of co-medication known to affect midazolam metabolism (according to the Farmacotherapeutische Kompas, www.fk.cvz.nl, and Micromedex)
研究者
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