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临床试验/NCT04666389
NCT04666389已完成不适用

The Role of Statins in the Prevention of Contrast-induced Acute Kidney Injury in Patients With Cardiovascular Diseases

I.M. Sechenov First Moscow State Medical University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2020年10月15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
150
试验地点
1
主要终点
Contrast-induced acute kidney injury

研究概览

简要总结

The aim of the study is to assess the role of statins and different dosage regimens in the prevention of contrast-induced acute kidney injury in patients with cardiovascular diseases requiring intravenous contrast media administration before computer tomography

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
None

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

  • Written informed consent
  • Indications for computer tomography with intravenous contrast media administration
  • Cardiovascular diseases (arterial hypertension, arrhythmia etc)

排除标准

  • Pregnancy
  • Statin therapy before inclusion in the study
  • Acute coronary syndromes
  • Contraindications for statins administration
  • Patients with chronic kidney disease stages 4-5
  • Contraindications for computer tomography with contrast media administration
  • Nephrotoxic drugs use (NSAIDS, vancomycin etc)

研究组 & 干预措施

Control group

Placebo Comparator

No statins being used for prevention

干预措施: Atorvastatin (Drug)

Low-dose statin therapy

Active Comparator

Atorvastatin 40 mg

干预措施: Atorvastatin (Drug)

High-dose statin therapy

Active Comparator

Atorvastatin 80 mg

干预措施: Atorvastatin (Drug)

结局指标

主要结局

Contrast-induced acute kidney injury

时间窗: 48-72 hours after contrast media administration

Contrast induced acute kidney injury is defined as the 25% rise (or 0,5 mg/dl) of serum creatinine from baseline assessed 48 hours after administration of contrast media.

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

Olga Mironova

Associate Professor

I.M. Sechenov First Moscow State Medical University

研究点 (1)

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