EUCTR2018-002226-22-AT进行中（未招募）1 期
The Impact of Target Temperature Management on Drug Metabolism - Cool PK
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Successful cardiopulmonary resuscitation (CPR) and target temperature management <34°C
- •>18 years of age
- •planned treatment with erythromycin, paracetamol, pantoprazole
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 26
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 26
排除标准
- •Increased inflammatory biomarkers at admission (C-reactive protein>5mg/dL), if available
- •Expected life expectancy <3 days
- •Patients with esophageal temperature <34.0°C at admission
- •Known liver dysfunction (i.e. liver cirrhosis, history of significant liver disorders)
- •Chronic kidney failure
- •Intake of known inducers or inhibitors of CYP2C19 or CYP3A4
- •Allergies of intolerances against any of the trial related substances
- •Prior erythromycin, pantoprazole or paracetamol treatment within 24 hours
- •Treatment with ciclosporin, tacrolimus, sirolimus, indinavir, ritonavir, saquinavir, or other drugs deemed relevant by the treating physician
- •Pregnancy or breastfeeding
- •Erythromycin: ongoing rhythm disturbances, such as ventricular tachycardias or ventricular fibrilliation
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