Effect of the Intensity of Continuous Renal Replacement Therapy in Patients With Cardiac Surgery Associated Acute Kidney Injury (CRITERIA STUDY)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 211
- 试验地点
- 1
- 主要终点
- death from any cause
研究概览
简要总结
The current international Continuous Renal Replacement Therapy (CRRT) replacement fluid doses of 35 ml/kg/h is better, but the result is according to white people, black people . It is Whether the best amount of replacement fluid for Chinese people, it is unclear. Especially,there is little evidence about the optimal dose from randomized trials in Cardiac surgery associated acute kidney injury (CSA-AKI )required CRRT,According to the clinical situation, the design of replacement fluid to 25 ml/kg/h.The observation of two doses 14 days, 28 days, 90 days survival and renal function.
详细描述
Acute kidney injury (AKI) is a major complication in patients with cardiac surgery and is an independent predictor of mortality. However, the optimal intensity of renal replacement therapy for such patients is still controversial. we randomly assigned the patients with Cardiac surgery-associated acute kidney injury (CSA-AKI) to continuous renal replacement therapy with different treatment dose (35ml / kg / h or 25ml/kg／h),The primary study outcome was death from any cause within 14, 28 and 90 days.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •> = 18 years of age, CRRT indications for acute kidney injury (RIFLE criteria) patients with cardiac surgery
排除标准
- •< 18 years old,
- •with chronic kidney disease,
- •dialysis history, to leave the ICU patients with acute kidney injury (AKI). - chronic kidney disease,
- •all causes kidney damage (pathology, hematuria, and radiographic abnormalities)> = 3 months or glomerular filtration rate < 60ml/min for 3 months or more.
结局指标
主要结局
death from any cause
时间窗: 14, 28 ,90 and 365 days after randomization
The primary study outcome was death from any cause within 14, 28 ,90 and 365 days after randomization.
次要结局
- renal outcome of survivors(14, 28 ,90 and 365 days after randomization)
研究者
Wei Shi
Director of renal division of Guangdong General Hospital
Guangdong Provincial People's Hospital