ISRCTN37719011已完成1 期
A phase I study to determine the pharmacokinetic profile, safety and tolerability of Sildenafil (REVATIO®) in cardiac surgery patients with chronic kidney disease
niversity of Leicester (UK)0 个研究点目标入组 36 人开始时间: 2014年1月10日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
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
- 性别
- All
入选标准
- •1. Adult cardiac surgery patients (>16 years and <80 years) undergoing cardiac surgery with moderately hypothermic cardiopulmonary bypass (CPB) (32-34°C) and blood cardioplegia
- •2. eGFR >15 and <90ml/min (International classification of Chronic Kidney Disease, CKD, Stage 2-4)
排除标准
- •1. Emergency or salvage procedure
- •2. Ejection fraction <30%
- •3. CKD Stage 1, defined as eGFR>90ml/min
- •4. CKD Stage 5, defined as eGFR<15ml/min or renal replacement therapy
- •5. Administration of potent CYP 3A4 inhibitors within 1 month prior to study participation
- •6. Any ongoing malignancy, or prior malignancy that currently requires treatment.
- •7. Patients allergic to any other PDE-5 Inhibitor
- •8. Patients who are participating in another interventional clinical study
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