NL-OMON23846已完成不适用
Pediatric Microdosing paracetamol: elucidating age-relatedchanges in oral drug absorption
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Erasmus MC
- 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
- •Patients need to fulfil all of the following inclusion criteria
- •- 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
- • Estimated risk for kidney injury or failure at least ‘risk for renal dysfunction’
- •according to pRIFLE criteria. Which means an estimated creatinine clearancedecreased by 25% or more, or urine output of <0.5 mL/kg per hour for 8
- • In need of renal dialysis
- •- Hepatic failure
- • >2SD in age appropriate liver enzyme measurement (ASAT and ALAT)
- •- Gastrointestinal disorders
- •Ileus, diarrhea, short bowel disease, underlying inflammatory bowel disease,
- •pancreatic insufficiency (e.g. cystic fibrosis), celiac disease
- •- Use of co-medication known to affect paracetamol metabolism (according to the
- •Farmacotherapeutische Kompas, www.fk.cvz.nl, and Micromedex,
研究者
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