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临床试验/NCT01400295
NCT01400295已完成不适用

Predictive Value of the Contrast Media Volume to Creatinine Clearance Ratio for the Risk of Contrast-Induced Nephropathy After Coronary Angiography

Guangdong Provincial People's Hospital1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2010年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
3,000
试验地点
1
主要终点
Contrast-Induced Nephropathy

研究概览

简要总结

To determine a relatively safe contrast media volume to creatinine clearance cut-off value to avoid contrast-induced nephropathy in patients following coronary angiography

详细描述

Contrast media volume to creatinine clearance (V/CrCl) ratios were obtained from consecutive consenting patients after coronary angiography. Receiver-operator characteristic (ROC) curves were used to identify the optimal sensitivity for the observed range of V/CrCl. The predictive value of V/CrCl for the risk of contrast-induced nephropathy was assessed using multivariate logistic regression.Subgroup analysis was performed on patients with creatinine clearance < 60 ml/min,diabetes,emergent angiography.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • patients who agreed to stay in the hospital for 2-3 days after coronary angiography
  • provided written informed consent

排除标准

  • pregnancy
  • lactation
  • intravascular administration of an contrast medium within the previous seven days
  • treatment with metformin,aminoglycosides,N-acetylcysteine (NAC),nonsteroidal anti-inflammatory drugs within the previous 48 h
  • intake of nephrotoxic drugs within the previous seven days
  • history of serious reactions to contrast mediums, severe concomitant disease renal transplantation , or end-stage renal disease necessitating dialysis
  • patients who died during coronary angiography

结局指标

主要结局

Contrast-Induced Nephropathy

时间窗: 48-72 h

Contrast-Induced Nephropathy was defined as an increase in serum creatinine of more than 0.5 mg/dl from the baseline within 48-72 h of contrast exposure

次要结局

  • Major adverse clinical events(1month)
  • An early abnormal increase in serum creatinine(24h)
  • An early abnormal increase in serum cystatin C(24h)

研究者

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

Jiyan Chen

MD

Guangdong Provincial People's Hospital

研究点 (1)

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