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临床试验/NCT01636089
NCT01636089已完成3 期

Bicarbonates Versus Saline for Contrast Induced Acute Kidney Injury Prevention in Intensive Care Unit

University Hospital, Caen3 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2012年2月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
300
试验地点
3
主要终点
contrast induced acute kidney injury

研究概览

简要总结

The aim of this study is to compare bicarbonates versus saline for prevention of contrast induced acute kidney injury in critically ill patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Double (Participant, Investigator)

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

  • •patient > 18 years old
  • •in intensive care unit since 24h and for up to 48 hours
  • •with contrast medium injection

排除标准

  • •patient under renal replacement therapy
  • •rise in creatinine > 26µmol/L within 48hours
  • •anuria within 12 hours
  • •cardiogenic pulmonary oedema
  • •pH > 7.50 or kaliemia < 3mmol/L
  • •pregnancy

研究组 & 干预措施

bicarbonates

Experimental

sodium bicarbonates 1,4%

干预措施: bicarbonates (Drug)

saline

Active Comparator

sodium chloride 0,9%

干预措施: saline (Drug)

结局指标

主要结局

contrast induced acute kidney injury

时间窗: 72 hours

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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