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临床试验/NCT01399203
NCT01399203Unknown不适用

Contrast Medium Volume and Contrast-induced Nephropathy After Percutaneous Coronary Intervention

Guangdong Provincial People's Hospital1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2010年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
2,000
试验地点
1
主要终点
Contrast-Induced Nephropathy

研究概览

简要总结

To investigate the predictive value of the contrast media volume to creatinine clearance (V/CrCl) ratio for the risk of contrast-induced nephropathy (CIN) (i.e., within 48-72 h) and to determine a relatively safe V/CrCl cut-off value to avoid CIN in patients following PCI

详细描述

contrast media volume to creatinine clearance (V/CrCl) ratios were obtained from consecutive consenting patients after unselective PCI. 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 CIN was assessed using multivariate logistic regression.

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
21 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 percutaneous coronary intervention
  • provided written informed consent
  • Creatinine Clearance:15-60ml/min

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 percutaneous coronary intervention

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(1 year)

研究者

申办方类型
Other

研究点 (1)

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