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临床试验/NCT01469624
NCT01469624Unknown不适用

Evaluating the Protective Effect of Pentoxifylline on Contrast Induced Nephropathy

Shiraz University of Medical Sciences1 个研究点 分布在 1 个国家开始时间: 2011年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
试验地点
1
主要终点
Serum Creatinine

研究概览

简要总结

Contrast induced nephropathy (CIN) is of great concern when using contrast media in the new era of medicine. CIN is defined as 25-50% relative increase, 0.5-1 absolute increase in serum creatinin value or 25% fall in GFR. The incidence of CIN is found to be 0% to 10% in general population and up to 50% in high risk population. High risk patients include those with chronic kidney disease (GFR<60 ml/min/1.73 m²) Diabetes Mellitus, congestive heart failure, anemia and advanced age. Amount and kind of contrast medium and decreased circulating blood volume are other important predictors of CIN. 50% of cases of CIN happen within 24 hours of contrast injection. Maximum creatinin levels are reached between 48-72 hours. It usually returns to previous levels in 7-10 days. Suggested mechanisms are renal vasoconstriction and tubular injury. N-acetylcysteine and hydration are proved to be protective against CIN and theophylline may have a role. In this study, it is hypothesized that pentoxifylline, a dimethylxanthine, can also protect renal cells from CIN. It has been observed that pentoxifylline improves oxygen delivery to ischemic tissues, diminishes oxidative damage to renal tissue and may also scavenge free radicals. Percutaneous coronary intervention is assumed a high risk procedure for developing CIN as the amount of contrast used in PCI is remarkable. Therefore, the patients undergoing PCI were selected for the trial. A prospective randomized trial will be conducted on patients undergoing PCI.

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
Double (Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All eligible consecutive patients who are admitted to the angiography center of university hospitals for PCI since April 2011 will be enrolled to enter the study.

排除标准

  • Serum creatinine above 1.5 mg/dl
  • Frank bleeding tendency
  • Those previously on pentoxifylline

研究组 & 干预措施

Test group

Experimental

This group receives pentoxifylline

干预措施: Pentoxifylline (Drug)

结局指标

主要结局

Serum Creatinine

时间窗: 48 hours after PCI

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

jamshid roozbeh

Clinical Professor

Shiraz University of Medical Sciences

研究点 (1)

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