NCT00252200已完成1 期
Low Dose Continuous Infusion of BNP (Nesiritide) in the Prevention of Renal Insufficiency Post Cardiopulmonary Bypass Cardiac Surgery.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Creatinine Clearance at 72 hours determined by the Cockroft-Gault formula
研究概览
简要总结
Use of BNP (nesiritide) vs placebo to help protect kidney function in patients undergoing heart bypass surgery.
详细描述
This is a randomized, double-blind, placebo controlled study of low dose nesiritide to prevent renal insufficiency after cardiopulmonary bypass surgery. Patients included are those with greater than mild renal insufficiency preoperatively as defined by having a creatinine clearance of less than 50 mL/minute determined by the Cockroft-Gault formula. The infusion of nesiritide (BNP) 0.005 mcg/Kg/minute or placebo begins 1 hour before surgery and runs for 24 hours started after the induction of anesthesia prior to cardiopulmonary bypass.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Patients > 18 years old, undergoing cardiac surgery requiring cardiopulmonary bypass with baseline creatinine clearance < 50 ml/min and who are not dialysis dependent.
排除标准
- •Cardiogenic shock or hypotension with systolic BP < 90 mmHg.
- •Patients with acute or chronic aortic dissection.
- •Patients who are enrolled in other studies that have an effect the renal function.
结局指标
主要结局
Creatinine Clearance at 72 hours determined by the Cockroft-Gault formula
时间窗: 72 hours post op
次要结局
- Need or absence of need for inotropic support in the 72 hour perioperative period(72 hours perioperative)
- Number of patients requiring dialysis during the hospitalization(before hospital discharge)
- Plasma aldosterone levels at 12 hours and 24 hours(12 hours and 24 hours postoperatively)
- Total time on ventilator, ICU length of stay, total length of stay in hospital(total length of hospital stay)
- pre and postoperative diuretic dose used(pre operative and postoperate)
研究者
研究点 (2)
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