NCT00621790已完成3 期
Efficacy of Fenoldopam in Reducing the Need for Renal Replacement Therapy After Cardiac Surgery. A Randomized Controlled Study.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 667
- 试验地点
- 19
- 主要终点
- Number of patients requiring Renal Replacement Therapy
研究概览
简要总结
Patients undergoing cardiac surgery could develop postoperative acute renal failure requiring renal replacement therapy.
Fenoldopam, already used for patients with hypertensive emergencies, could improve renal function in critically ill patients with or at risk for acute renal failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients
- •who underwent cardiac surgery
- •have Risk of Acute Renal Failure (R of RIFLE score)
排除标准
- •already on renal replacement therapy
- •study drug in the past 30 days
- •inclusion in other protocols
研究组 & 干预措施
Fenoldopam
Experimental
Fenoldopam 0.1 ug/kg/min (from 0.025 to 0.3 ug/kg/min) for up to 4 days
干预措施: fenoldopam (Drug)
Placebo
Placebo Comparator
Placebo (normosaline), continuous perfusion
干预措施: placebo (Drug)
结局指标
主要结局
Number of patients requiring Renal Replacement Therapy
时间窗: participants will be followed for the duration of intensive care unit stay, an expected average of one week
次要结局
- Number of dead patients.(Participants will be followed for 1 year.)
研究者
Giovanni Landoni
Head of Research, Anesthesia and Intensive Care Department
Università Vita-Salute San Raffaele
研究点 (19)
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