NL-OMON44350已完成不适用
Pediatric microdosing midazolam: elucidating age-related changes in oral drug absorption - PedMic Mida
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
- 年龄范围
- 2 至 11（—）
入选标准
- •- Age 0 to 6 years inclusive
- •- At least 36 weeks of post conceptual age or body weight 2.5 kg or more
- •- Receiving midazolam IV
- •- Parental informed consent
- •- Intravenous or intra-arterial access for blood sampling
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 failure according to the pRIFLE criteria, i.e. estimated creatinine clearance decreased by 75% or an urine output of <0.3 ml/kg/h for 24h or anuric for 12 hours.
- •- Acute liver failure AST/ALT >2 times the upper limit for age
- •- Gastrointestinal disorders
- •Ileus, diarrhoea, short bowel disease, underlying inflammatory bowel disease, pancreatic insufficiency (e.g. cystic fibrosis), celiac disease.
- •- Use of most relevant co-medication known to affect midazolam metabolism (according to the *Cytochrome P450 Drug Interactions Table*, listed in appendix 1) ;INHIBITORS
- •Indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, nefazodone, saquinavir, telithromycin, aprepitant, erythromycin, fluconazole, grapefruit juice, verapamil, diltiazem, cimetidine , amiodarone, chloramphenicol, ciprofloxacin, delaviridine, diethyldithiocarbamate, fluvoxamine, gestodene, imatinib, mibefradil, mifepristone, norfloxacin, norfluoxetine, star fruit, voriconazole
- •Efavirenz, nevirapine, barbiturates, carbamazepine, efavirenz, glucocorticoids, modafinil, nevirapine, oxcarbazepine, phenobarbital, phenytoin, pioglitazone, rifabutin, rifampin, St. John*s wort, troglitazone
研究者
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