N-acetylcysteine and Fenoldopam Protect the Renal Function of Patients With Chronic Renal Insufficiency Undergoing Cardiac Surgery.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 主要终点
- Length of post-operative hospital stay
研究概览
简要总结
Patients with abnormal kidney function are at increased risk for complications following heart surgery, including worsening kidney function possibly requiring dialysis, a prolonged stay in the critical care unit and hospital, and the increased risk of death. Prior attempts at kidney protection for heart surgery patients have had mixed results. Two medicines, fenoldopam and N-acetylcysteine, have been shown to protect kidney function in other circumstances that cause kidney stress. The purpose of this study is to determine whether these medications will help to maintain the function of diseased kidneys during heart surgery.
详细描述
This is a randomized, double-blinded, placebo-controlled trial to evaluate fenoldopam and N-acetylcysteine (NAC) individually, and together, as renal protective agents for patients with renal insufficiency undergoing heart surgery. Subjects have chronic renal insufficiency with creatinine clearance (CrCl) </= 40cc/min but not on pre-operative dialysis, and receive: NAC 600 mg by mouth (po) twice a day (bid) or placebo starting 24 hours pre-operative and continuing through the day of surgery; and/or fenoldopam 0.1 mcg/kg/min intravenous (IV) or saline placebo at anesthetic induction and continuing for 48 hours. Outcome data include: nadir, post-operative day 3 and post-operative day 14 CrCl, time to CrCl nadir, length of Intensive Care Unit (ICU) stay, length of post-operative hospital stay, hospital costs, mortality, and the need for hemodialysis. Intraoperative and post-operative pressor use is being monitored. The enrollment will include 80 patients (20 in each group).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Double
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
- •Chronic creatinine clearance </= 40cc/h
- •Pre-operative cardiac surgery
排除标准
- •Pre-operative ongoing dialysis
- •Nausea and vomiting
- •Uncontrolled glaucoma
- •Allergy to metabisulfite
- •Enrollment in another clinical study within 30 days
- •Pregnancy
- •Acute renal failure
研究组 & 干预措施
NAC and fenoldopam
Both N-acetylcysteine and fenoldopam as above
干预措施: fenoldopam (Drug)
NAC
N-acetylcysteine started day prior to surgery, continued through night of surgery
干预措施: N-acetylcysteine (Drug)
fenoldopam
fenoldopam started at surgery continued for 24 hours
干预措施: fenoldopam (Drug)
NAC and fenoldopam
Both N-acetylcysteine and fenoldopam as above
干预措施: N-acetylcysteine (Drug)
结局指标
主要结局
Length of post-operative hospital stay
时间窗: 30-day
Length of post-operative critical care stay
时间窗: 30-day
Creatinine clearance post-operative days 3, 14, and nadir
时间窗: 14 day
次要结局
- Days to post-operative creatinine clearance nadir(14 day)
- Intraoperative and post-operative pressor use (pressor-hours)(48 hour)
- Hospital costs(30-day)
- Mortality(30-day)
研究者
Linda F. Barr, M.D.
Primary Investigator
Pulmonary Critical Care Associates of Baltimore