Prevention of Contrast-Induced Nephropathy: a Randomized Controlled Trial of Saline + Furosemide + Mannitol in High Risk Patients Undergoing Cardiac Angiography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Proportion of patients that develop contrast-induced nephropathy after cardiac angiography
研究概览
简要总结
Patients with pre-existing kidney disease are at high risk of acute renal failure when exposed to radio-contrast dyes, for example during a cardiac angiogram.
The investigators hypothesize that an infusion of saline + furosemide + mannitol will reduce rates of contrast-induced nephropathy when compared with saline infusion controls.
详细描述
Patients with pre-existing kidney disease are at high risk of acute renal failure when exposed to radio-contrast dyes, for example during a cardiac angiogram.
We hypothesize that an infusion of saline + furosemide + mannitol will reduce rates of contrast-induced nephropathy when compared with saline infusion controls.
We define an episode of contrast nephropathy using the conventional often published definition of a 25% relative increase in serum creatinine OR a 44 umol absolute increase in serum creatinine within 48 hours of contrast 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age > 21 years
- •serum creatinine > 150 umol/L
- •able and willing to provide informed consent
排除标准
- •known hypersensitivity to contrast, furosemide, or mannitol
- •unable to tolerate a fluid load (e.g., acute pulmonary edema)
- •ESRD, on dialysis
- •previous enrollment in this study or previous contrast administration with the last 2 weeks
- •refusal by treating physician
研究组 & 干预措施
Intervention
Saline hydration + mannitol + furosemide
干预措施: intravenous saline hydration + mannitol + furosemide (Drug)
Controls
Saline hydration without mannitol or furosemide
干预措施: intravenous saline hydration (Drug)
结局指标
主要结局
Proportion of patients that develop contrast-induced nephropathy after cardiac angiography
时间窗: Within 48 hours of angiogram
次要结局
- Safety of the intervention based on transfer to ICU, need for dialysis, or death(During hospitalization episode)
- Adverse clinical events and measures of renal function(6 weeks post-angiogram)
- Health related quality of life(6 weeks post-angiogram)
- Subgroup analyses based on (a) diabetes; (b) amount of contrast; and (c) baseline creatinine(Within 48 hours of angiogram)