跳至主要内容
临床试验/NCT00837057
NCT00837057Unknown4 期

A Randomized Controlled Multi-Center Trial of the Early Application of CRRT in Patients With Severe Sepsis or Septic Shock

Asan Medical Center1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2009年2月最近更新:
适应症

试验速览

阶段
4 期
入组人数
60
试验地点
1
主要终点
Death from all causes at 28 days after randomisation

研究概览

简要总结

Severe sepsis or septic shock with acute kidney injury shows high mortality in intensive care unit. A few studies have shown CRRT relating the clinical improvement seems to be related to the early initiation of therapy. But there is no consensus for proper time of CRRT may improve the prognosis.

The study is a prospective randomized one center trial comparing two treatments in patients suffering from septic shock complicated with acute renal failure admitted to ICU, treated either early by CRRT (35 ml/kg/h) or by conventional RRT.

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 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Septic shock (Bone criteria) for less than 14D
  • RIFLE criteria : Injury or Failure or nearly anuria more than 2hr
  • Age over 18 years
  • Written informed consent by next of kin.

排除标准

  • Cirrhosis child class C
  • CRF or ESRD
  • Too high APACHE II & SOFA score at admission
  • Age over 80 years
  • Life expectancy less than 3 months (metastatic cancer - hepatoma, lung ca.)

结局指标

主要结局

Death from all causes at 28 days after randomisation

时间窗: 28 day

次要结局

  • Death within the in the intensive care unit. Death within 90 days of randomisation. Death prior to hospital discharge. Length of ICU stay. The need for and duration of other organ support(90 day)

研究者

申办方类型
Other

研究点 (1)

Loading locations...

相似试验