临床试验/NCT02029820

NCT02029820Unknown3 期

RenalGuard System for Prevention of Contrast Induced Nephropathy - A Randomized Trial

Hospital Sao Lucas da PUCRS2 个研究点分布在 1 个国家目标入组 210 人开始时间: 2012年8月最近更新: 2014年1月8日

适应症

试验速览

阶段: 3 期
发起方: Hospital Sao Lucas da PUCRS
入组人数: 210
试验地点: 2
主要终点: Incidence of contrast-induced nephropathy

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to determine whether hydration with intravenous saline matched with urine output, using the device RenalGuard is superior to standard hydration with saline to prevent contrast-induced nephropathy.

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: 否

入选标准

•serum creatinine >1.2mg/dl
•glomerular filtration rate (GFR) < 60ml/min

排除标准

•acute renal failure
•use of radiological contrast in the latest 7 days
•Current use of N-acetylcysteine or hydration of sodium bicarbonate
•Patients in dialysis
•Emergency procedures

结局指标

主要结局

Incidence of contrast-induced nephropathy

时间窗: 72 hours

Contrast-induced nephropathy defined as an increase of serum creatinine of 0.5mg/dl or 25% in pre procedure serum creatinine at 72h after procedure

次要结局

未报告次要终点

研究者

发起方

Hospital Sao Lucas da PUCRS

申办方类型

Other

责任方

Principal Investigator

主要研究者

Vitor Osorio Gomes

MD, PhD

Hospital Sao Lucas da PUCRS

研究点 (2)

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