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临床试验/NCT03759158
NCT03759158已完成不适用

N-Acetyl Cysteine in the Prevention of Contrast Induced Nephropathy in Cirrhosis of Liver-NEPHRO Trial

Institute of Liver and Biliary Sciences, India1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年12月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Development Of CIN (Contrast-Induced Nephropathy) (> 25% baseline creatinine) in both groups.

研究概览

简要总结

Contrast induced nephropathy has an incidence of 7-11 % in patients undergoing Contrast imaging for various conditions. The risk associated with the development of CIN are still under evaluation. Even with patients having normal kidney functions there is a risk of contrast induced nephropathy hence the need for markers which could predict injury. Cirrhosis of liver predisposes patient to Kidney abnormalities as these patients lower renal reserve and can have various conditions like Hepatorenal syndrome, Sepsis, ATN. Contrast imaging is vital for ruling out conditions like Hepatocellular Carcinoma in patients of cirrhosis of liver. Presently there is no study in cirrhosis of liver which studies the Effect of N-acetyl cysteine before and after contrast imaging in the prevention Of CIN. The incidence of CNI is cirrhosis is also an avenue which requires more studies and also there is a need for formulation of a Score to predict this CIN. Hence this study is being done to assess the incidence of CNI and the role of N-Acetyl cysteine in Preventing CNI.

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

入选标准

  • Age-18-70 years
  • Normal kidney parameters (Creatinine below <1 ,Creatinine clearance >60)
  • Cirrhosis of liver
  • eGFR>60ml/min

排除标准

  • Chronic kidney disease
  • H/o anaphylaxis to contrast
  • Prior h/o AKI
  • GFR<60 ML/MIN
  • Prior H/o TACE/HVPG /Contrast ECHO in the last 4 weeks

研究组 & 干预措施

NAC Arm

Experimental

NAC 1200 mg twice daily one day prior to the procedure and on the day of the procedure.

干预措施: N-Acetyl Cysteine (Drug)

Placebo

Placebo Comparator

干预措施: Placebo Oral Tablet (Drug)

结局指标

主要结局

Development Of CIN (Contrast-Induced Nephropathy) (> 25% baseline creatinine) in both groups.

时间窗: Day 2

次要结局

  • Mean change in serum creatinine from baseline in both groups(Day 6)
  • Adverse events of N-Acteyl Cysteine in both groups(Day 6)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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