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临床试验/NCT01210456
NCT01210456Unknown3 期

The Prevention Contrast-Induced Acute Kidney Injury With the Triple Combination of Hydration With Physiological Saline, N-Acetylcysteine and Sodium Bicarbonate

Tokushukai Medical Group1 个研究点 分布在 1 个国家目标入组 458 人开始时间: 2009年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
发起方
入组人数
458
试验地点
1
主要终点
Development of contrast-induced acute kidney injury

研究概览

简要总结

Contrast-Induced Acute Kidney Injury(CIAKI) was defined as an absolute increase in serum creatinine of more than or equal to 0.3mg/dl (≥ 26.4 μmol/l), a percentage increase in serum creatinine of more than or equal to 50% (1.5-fold from baseline) within 48 hours of intravascular contrast administration in the absence of any alternative causes, or a reduction in urine output documented oliguria of less than 0.5 ml/kg per hour for more than six hours.

It is the common cause of new hospital-acquired renal insufficiency. The occurrence of CIAKI may be influenced by pre-existing renal insufficiency, diabetic nephropathy, dehydration, congestive heart failure, concurrent administration of nephrotoxic drugs, or the dose and type of contrast media used. Previous studies have shown the independent effectiveness of several agents in preventing CIAKI.

Even now, hydration is crucial for preventing CIAKI. Since CIAKI is presumed to be caused by free radical generation, N-Acetylcysteine, which is a potent free radical scavenger, is shown to be effective in preventing nephropathy. At the same time, because free radical formation is promoted by an acidic environment, bicarbonate, which alkalinizes renal tubular fluid, has been shown to reduce renal involvement.

These days, some studies have shown that hydration with sodium bicarbonate plus N-Acetylcysteine was effective and safe in the prevention of CIAKI. In these studies, bicarbonate was used for both alkalinizing renal tubular fluid and hydration. However, if we want to do hydration, we can use saline and if we want to alkalinize renal tubular fluid, we might use bicarbonate by bolus injection.

Actually, bicarbonate for hydration is prepared at sterile preparation room in a hospital, which is very cumbersome procedure and increase in cost. This is one of the reasons that bicarbonate for hydration use does not become common with wide clinical application.

In past issues, though it differs depending on the level of the renal dysfunction, the probability of CIAKI was 8-33% when hydration was administered, 5-15% when hydration and N-Acetylcysteine were administered, and 1.8-1.9% when bicarbonate and N-Acetylcysteine were administered.

Thus, we can hypothesize the combination of N-Acetylcysteine and bicarbonate will play a complementary role in preventing contrast-induced nephropathy.

This is the rational for this study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • serum creatinine more or equal than 1.1mg/dL
  • procedures using contrast media

排除标准

  • congestive heart failure
  • serum creatinine less than 1.1mg/dl
  • allergy to contrast media
  • preexisting dialysis
  • emergency catheterization
  • recent exposure to contrast within 2 days of the study
  • refuse to entry this study
  • dialysis after procedure

研究组 & 干预措施

Physiological Saline and N-Acetylcysteine

Active Comparator

干预措施: Physiological Saline, N-Acetylcysteine and Sodium Bicarbonate (Drug)

Physiological Saline, N-Acetylcysteine and Sodium Bicarbonate

Active Comparator

干预措施: Physiological Saline, N-Acetylcysteine and Sodium Bicarbonate (Drug)

结局指标

主要结局

Development of contrast-induced acute kidney injury

时间窗: within 48 hours

Contrast-Induced Acute Kidney Injury(CIAKI) was defined as an absolute increase in serum creatinine of more than or equal to 0.3mg/dl (≥ 26.4 μmol/l), a percentage increase in serum creatinine of more than or equal to 50% (1.5-fold from baseline) within 48 hours of intravascular contrast administration in the absence of any alternative causes, or a reduction in urine output documented oliguria of less than 0.5 ml/kg per hour for more than six hours.

次要结局

  • Requirement of dialysis(6 months)
  • Requirement of hospitalization and death(6 months)

研究者

发起方
Tokushukai Medical Group
申办方类型
Other
责任方
Principal Investigator
主要研究者

Daisuke Hachinohe

Sapporo Higashi Tokushukai Hospital

Tokushukai Medical Group

研究点 (1)

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