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临床试验/NCT00811109
NCT00811109已完成2 期

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.

University Hospital, Caen2 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2008年12月最近更新:
适应症

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

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)

研究者

申办方类型
Other

研究点 (2)

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