HEMOTOL: Effects of New Dialysis On-line Monitoring Devices on Hemodynamic Stability During Intermittent Hemodialysis in Critically Ill Patients With Acute Kidney Injury : a Prospective Randomized Study.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Intra-Dialytic Hypotension
研究概览
简要总结
The purpose of this randomized controlled study is to compare the effects of different new dialysis on-line monitoring devices on hemodynamic stability during intermittent hemodialysis in critically ill patients with acute kidney injury.
详细描述
Acute kidney injury (AKI) is associated with high mortality and morbidity rates in critically ill patients despite advances in renal replacement therapy (RRT). Over the last few years, new devices in dialysis equipment, such as blood temperature and blood volume on-line monitors, have been developed to improve hemodynamic tolerance, and these new modalities have demonstrated their positive impact on decrease in intra-dialytic hypotension rate in chronic hemodialysis patients. In order to evaluate these new devices in critically ill patients with acute kidney injury we decided to conduct a prospective randomized controlled trial.
We based calculation of the sample size on a power analysis that assumed an expected decrease in intra-dialytic hypotension rate of 40% (from a crude intra-dialytic hypotension rate of 30% to 18%) in groups B and C, compared with group A. Analysis is done by intention to treat, according to prescribed new dialysis on-line monitoring devices.
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
- 否
入选标准
- •Age > 18 years
- •Acute Kidney injury requiring intermittent hemodialysis
排除标准
- •Age < 18 years
- •End-stage renal failure
- •Inclusion in other protocol
- •Absence of consent
结局指标
主要结局
Intra-Dialytic Hypotension
时间窗: 60 days
次要结局
- Compliance to treatment; intra-dialytic complications; dialysis dose; blood temperature control; blood volume control(60 days)
