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临床试验/IRCT2015050722134N1
IRCT2015050722134N1已完成2 期

Comparison of N-acetylcysteine, Ascorbic acid and Normal saline effect in prevention of contrast-induced nephropathy on the patient’s undergone coronary angiography

Vice chancellor for research,Shahrekord University of Medical Sciences0 个研究点目标入组 120 人开始时间: 待定最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
120

研究概览

简要总结

BACKGROUND: Considering the crucial role of appropriate preventative strategies in reducing
the rate of contrast-induced nephropathy (CIN) occurrence and its related morbidity and
mortality, the effect of N-acetylcysteine (NAC), ascorbic acid (AA), and normal saline (NS) was
investigated in the patient’s undergone coronary angiography.
METHODS: In this clinical trial, 120 patients scheduled for elective coronary angiography with serum
creatinine (Cr) level > 1.5 mg/dl or glomerular filtration rate (GFR) = 60 selected by convenience
method. Selected patients were allocated in three treatment groups randomly to receive oral NAC
(600 mg/twice daily) plus NS (100 ml/hour) (Group A), oral AA (250 mg/twice daily) plus NS (100
ml/hour) (Group B) and NS (100 ml/hour) (Group C), respectively. The occurrence of CIN was
evaluated based on serum Cr and GFR in three studied groups, before and after angiography
procedure. The analysis of variance and paired t-test were used for data analysis by SPSS.
RESULTS: The serum Cr increased and GFR decreased significantly during the intervention in three
groups (P < 0.010). However, the amounts of these changes were equal between groups (P > 0.050).
CONCLUSION: The study showed that nor the addition of NAC neither the addition of AA to
sodium chloride infusion has more beneficial effect than hydration with sodium chloride, in the
prevention of CIN.

研究设计

研究类型
Interventional

入排标准

年龄范围
no limit 至 no limit(—)
性别
All

入选标准

  • creatinine level of >1.5mg/dl; glomerular filtration rate ( GFR) = 60
  • Exclusion criteria: Oliguria (<400cc/24hours); severe heart failure with left ventricular ejection fraction (LVEF) < 35%; contrast-agent hypersensitivity; pregnancy; lactation; acute renal failure; Vitamin C supplements

排除标准

  • 未提供

研究者

发起方
Vice chancellor for research,Shahrekord University of Medical Sciences

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