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临床试验/NCT00312117
NCT00312117已完成3 期

A Randomized Trial for Prevention of Contrast Nephropathy With Sodium Bicarbonate

Kaiser Permanente2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2006年1月最近更新:
适应症
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
2
主要终点
development of contrast induced nephropathy, defined by a decrease in glomerular filtration rate (GFR) by 25% or more

研究概览

简要总结

Contrast nephropathy (CN) is a common cause of renal failure associated with prolonged hospitalization, significant morbidity/mortality, and cost. In addition, these patients may require temporary or permanent hemodialysis which, in turn, is associated with further morbidity, mortality, and cost. CN has been reported to account for 10% of hospital acquired renal failure. In recent years, studies have investigated preventive therapies with mixed results. Fenoldopam was found to be ineffective in a large randomized trial. Dopamine has been shown to be ineffective as a preventive strategy. Hemofiltration has been shown to be beneficial (New England Journal of Medicine [NEJM] 2003) but is costly and not practical. Mucomyst has shown mixed results. The single strategy which most would agree as being beneficial remains hydration, most commonly with intravenous 0.9% normal saline. Most recently, sodium bicarbonate has been shown to be beneficial in a small randomized trial (n=119). It is clear that the most cost effective strategies for treatment of CN should be aimed at prevention.

The general question is: "Is a sodium bicarbonate solution more efficacious in preventing contrast nephropathy compared to normal saline?" The general hypothesis is that sodium bicarbonate will be more efficacious.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

  • GFR < 60 mL/min/1.73m
  • GFR will be adjusted by a correction factor as reported by our laboratory for patients self identifying as black.
  • > 18 years and have at least one of the following risk factors for contrast nephropathy: diabetes (type 2), congestive heart failure, hypertension (> 140/90), or age >
  • Both inpatients and outpatients will be offered enrollment.

排除标准

  • Patients unable to give consent
  • Already receiving sodium bicarbonate solution
  • Undergoing emergency cardiac catheterization
  • Receiving a contrast agent other than Oxilan
  • On hemodialysis
  • Recent exposure to contrast within 2 days
  • Pulmonary edema
  • Active congestive heart failure
  • Severe valvular abnormality
  • Recent significant change in kidney function (> 15% over 2d)
  • One kidney
  • Kidney transplant status

结局指标

主要结局

development of contrast induced nephropathy, defined by a decrease in glomerular filtration rate (GFR) by 25% or more

次要结局

  • difference in GFR and creatinine from baseline and 2-8 weeks later
  • need for hemodialysis
  • change in serum creatinine
  • difference in hospital duration between groups
  • difference of baseline to lowest GFR and highest creatinine between groups
  • 30 day mortality

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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