Randomized Controlled Study for Evaluation of the Impact of Red Wine, White Wine and Beer Intake on Contrast-Medium Induced Acute Kidney Injury
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- CI-AKI incidence
研究概览
简要总结
Patients with impaired renal function are at elevated risk for development of contrast-medium induced acute kidney injury (CI-AKI). CI-AKI is associated with increased risk for cardiovascular morbidity and mortality. Effective CI-AKI prevention strategies are needed.
The RenPro-II-WINE Trial was designed to test the hypothesis whether moderate red wine consumption prior to contrast-medium use is effective in CI-AKI prevention.
Consecutive patients with impaired renal function undergoing elective coronary angiography will be assigned in one of four treatment arms: a. control patients receiving standard care b. patients receiving standard care plus red wine c. patients receiving standard care plus white wine d. patients receiving standard care plus beer This study will give important answers on how to prevent CI-AKI in patients with impaired renal function undergoing contrast media exposure.
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
- Single (Outcomes Assessor)
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
- •age >= 18 years
- •impaired renal function (baseline estimated glomerular filtration rate of <60 ml/min)
- •at least three of following comorbidities: hypertension, diabetes mellitus without insulin therapy, heart failure NYHA III and/or left ventricular ejection fraction <35%, peripheral artery disease, coronary artery disease
排除标准
- •known alcohol addiction
- •severe renal impairment (estimated glomerular filtration rate <15 ml/min and/or in chronic dialysis program
- •Recent (<=30 days) contrast media exposure
- •insulin therapy
- •Patients enrolled in concomitant studies
- •fertile women
研究组 & 干预措施
Red Wine
Patients assigned to red wine group will receive standard care plus two doses of red wine: the evening before contrast-medium use and the morning of contrast-medium exposure
干预措施: Red wine (Dietary Supplement)
White wine
干预措施: White wine (Dietary Supplement)
Beer
干预措施: Beer (Dietary Supplement)
Control
Patients assigned to control group will receive standard care. Patients receive ordinary still water without alcohol the evening before(7.8 ml per kg bodyweight) and 60-120 minutes before contrast exposure (at least 3.9 ml per kg bodyweight)
结局指标
主要结局
CI-AKI incidence
时间窗: <48 hours after contrast-medium exposure
Increment of serum-creatinin of 0.5 mg/dl or of at least 25% in 48 hours after contrast medium intake from baseline.
次要结局
- Biomarkers assessing acute kidney injury(<48 hours)
研究者
Dr. Fikret Er
MD, Assistant Professor
University of Cologne