NCT00982527已完成3 期
Intraoperative Fenoldopam Infusion in Children Requiring Cardiopulmonary Bypass During Cardiac Surgery
Bambino Gesù Hospital and Research Institute1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2009年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Reduction of urinary and/or serum levels of biomarker NGAL in treated group versus controls
研究概览
简要总结
The purpose of this study is to determine whether fenoldopam infusion during cardiopulmonary bypass in young children with congenital heart disease is able to reduce indicators of acute kidney injury (biomarkers reduction, diuresis increase) compared to a control group.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 1 Day 至 365 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with congenital heart disease, less than one year old, undergoing surgery with the use of cardiopulmonary bypass
排除标准
- •Children over one year old, correction for ventricular or atrial septal defect, need for deep hypothermic circulatory arrest, preoperative renal dysfunction.
研究组 & 干预措施
Placebo
Placebo Comparator
Saline blinded infusion
干预措施: Placebo (Drug)
Placebo
Placebo Comparator
Saline blinded infusion
干预措施: Fenoldopam (Drug)
Fenoldopam
Active Comparator
Drug infusion
干预措施: Placebo (Drug)
Fenoldopam
Active Comparator
Drug infusion
干预措施: Fenoldopam (Drug)
结局指标
主要结局
Reduction of urinary and/or serum levels of biomarker NGAL in treated group versus controls
时间窗: End of surgery and 12 hours postoperatively
次要结局
- Reduction of urinary and/or serum levels of cystatin C, increase of diuresis and improvement of perfusion markers in treated group versus controls(End of surgery and 12 hours postoperatively)
研究者
Zaccaria Ricci
medical doctor
Bambino Gesù Hospital and Research Institute
研究点 (1)
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