Risk of QT-prolongation and Torsade de Pointes in Patients Treated With Acute Medication in a University Hospital
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- KU Leuven
- 入组人数
- 178
- 试验地点
- 1
- 主要终点
- change in QTc-interval (corrected for heart rate)
研究概览
简要总结
A prospective, observational study in a university hospital (UZ Leuven). Patients are included when they are treated with a potentional QT-prolonging drug: haloperidol for delirium, antibiotics (moxifloxacin, levofloxacin, azithromycin, clarithromycin, erythromycin, co-trimoxazole), antimycotics (ketoconazole, itraconazole, fluconazole, voriconazole), methadone, tacrolimus and oral oncolytics.
An ECG is taken before the administration of the drug and 3-5 days after starting the drug to investigate the change in duration of the QTc-interval. Risk factors for developing QT-prolongation will be documented. Together with ECG2, an additional blood sample will be collected to measure the blood concentration of the drug.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •treatment with a potentional QT-prolonging drug of our list
- •inpatient of UZ Leuven, admitted on one of the participating wards
排除标准
- •< 18 years old
- •DNR-code 3
- •not possible to take an ECG before the start of haloperidol
研究组 & 干预措施
patients treated with a potentional QT-prolonging drug
干预措施: Haloperidol, azi/clari/erythromycin, levo/moxifloxacin, co-trimoxazole, vori/keto/flu/itraconazole, methadone, tacrolimus, sunitinib (Drug)
结局指标
主要结局
change in QTc-interval (corrected for heart rate)
时间窗: before and 3-5 days after the start of a potentional QT-prolonging drug
次要结局
未报告次要终点