NL-OMON39097已完成不适用
Pediatric microdosing: elucidating age-related changes in oral absorption - PedMic
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
研究概览
简要总结
Trial ended prematurely
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 11（—）
入选标准
- •Age 0 to 6 years inclusive
- •At least 32 weeks of post conceptual age
- •Intravenous or intra-arterial access for blood sampling in place
- •Receiving paracetamol 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
- •Renal disorders
- •- In need of renal dialysis
- •- Estimated risk for kidney injury or failure at least 'risk for renal dysfunction' according to pRIFLE criteria. Which means an estimated creatinine clearance decreased by 25% or more, or urine output of <0.5mL/kg per hour for 8 hours.
- •Hepatic failure:
- •- >2SD in age appropriate liver enzymes measurement (ASAT and ALAT)
- •Gastrointestinal disorders
- •- Ileus, diarrhea, short bowel disease, underlying inflammatory bowel disease, pancreatic insufficency, (e.g. cystic fibrosis), celiac disease
- •Use of co-medication known to affect paracetamol metabolism (according to the Farmacotherapeutische Kompas, www.fk.cvz.nl)
研究者
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