Single System Double Blinded Trial to Evaluate the Effect of Pre-operative Treatment With DigiFab to Prevent Post-operative Acute Kidney Injury (AKI) in Patients at High Risk for AKI Undergoing Cardiac Bypass Graft Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 267
- 试验地点
- 2
- 主要终点
- Renal Function
研究概览
简要总结
Acute kidney injury (AKI) occurs in up to 30% of patients undergoing coronary artery bypass graft (CABG) surgery, and often requires patients to go on dialysis. In patients needing dialysis, the risk of dying is very high.There are no known therapies to reduce the chance of developing kidney damage after heart surgery. There is evidence that patients with high levels of a substance called ouabain have an increased risk of developing kidney damage. This study is testing the hypothesis that giving a medication called DigiFab to lower the ouabain levels will reduce the risk of developing kidney damage after heart surgery.
详细描述
This is a randomized double-blinded study investigating the role of DigiFab in patients with elevated risk of acute kidney injury undergoing CABG surgery. University of Maryland Medical Center (UMMC) and University of Maryland St Joseph Medical Center (UMSJMC) patients who are undergoing CABG, meet the inclusion criteria and provide consent will be enrolled in this study and randomized to either DigiFab arm or the placebo (vehicle) arm. The study involves a follow up period of 72 hours post CABG surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Investigational pharmacy will provide active drug or placebo
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
- •Undergoing coronary artery bypass surgery
- •glomerular filtration rate > 15 History of Diabetes Mellitus or GFR < 60
排除标准
- •Allergy to Digifab Contrast dye within 3 days Creatinine > 25% above baseline
研究组 & 干预措施
Digifab, EO > 360
Digifab intravenous in subject with baseline ouabain concentration > 360 pm
干预措施: Baseline EO > 360 pM (Diagnostic Test)
Placebo, EO > 360
saline intravenous n subject with baseline ouabain concentration > 360 pm
干预措施: Placebo (Other)
Digifab, EO > 360
Digifab intravenous in subject with baseline ouabain concentration > 360 pm
干预措施: Digoxin Antibodies Fab Fragments (Drug)
Placebo, EO > 360
saline intravenous n subject with baseline ouabain concentration > 360 pm
干预措施: Baseline EO > 360 pM (Diagnostic Test)
Digifab, EO < 360
Digifab in subject with baseline ouabain concentration < 360 pm
干预措施: Digoxin Antibodies Fab Fragments (Drug)
Digifab, EO < 360
Digifab in subject with baseline ouabain concentration < 360 pm
干预措施: EO < 360 pM (Diagnostic Test)
Placebo, EO < 360
Subjects who received Placebo in n subject with baseline ouabain concentration < 360 pm
干预措施: Placebo (Other)
Placebo, EO < 360
Subjects who received Placebo in n subject with baseline ouabain concentration < 360 pm
干预措施: EO < 360 pM (Diagnostic Test)
结局指标
主要结局
Renal Function
时间窗: 72 hours
Change in glomerular filtration rate (measured by Cockcroft-Gault Formula), mL/min per 1.73 m2 from baseline to 72 hours
次要结局
- AKI(3 days)
研究者
Stephen Gottlieb
Professor of Medicine
University of Maryland, Baltimore