NCT02872155已完成3 期
Comparative Study of the Efficacy of Oral Versus Intravenous Hydration as a Preventive Measure of Contrast-induced Nephropathy (CIN) in Patients
David Garcia Cinca1 个研究点 分布在 1 个国家目标入组 264 人开始时间: 2017年7月4日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 264
- 试验地点
- 1
- 主要终点
- Proportion of contrast induced nephropathy
研究概览
简要总结
This study evaluates if oral hydratation is as effective as endovenous hydratation in the prophylaxis of contrast-induced nephropathy in patients renal insufficiency grade III under study conducting contrasted computed 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both sexes over 18 years
- •Candidates for a study with computed tomography and intravenous contrast
- •A glomerular filtration rate between 30 and 45 mL / min including both determinations
- •They have signed the written informed consent after being informed of the objectives and the nature of the case or be unable to have the authorization or agreement of its
排除标准
- •refuse to participate in the study
- •pregnancy or lactation
- •Other risk factors for Contrast Induced Nephropathy: diabetes mellitus type I, have an age of 75 years or above, heart failure (defined by a scale New York Heart Association 3 or 4), hypotension (defined as systolic blood pressure <100), being treated with nephrotoxic medications.
- •Any disease or a history that, in the investigator's opinion, could confound the results of the study or pose an additional risk to patient treatment.
研究组 & 干预措施
Oral hydratation
Experimental
干预措施: Oral hydratation (Other)
Endovenous hydratation
Active Comparator
干预措施: Bicarbonate endovenous hydratation (Drug)
Endovenous hydratation
Active Comparator
干预措施: Saline endovenous hydratation (Drug)
结局指标
主要结局
Proportion of contrast induced nephropathy
时间窗: 48-72 hours after the completion of the computed tomography
Contrast induced nephropathy defined as a creatinine increase\> 0.5 mg / dl comparing the initial blood test to the blood test performed after 48-72 hours to the completion of the computed tomography
次要结局
- Need for hemodialysis(15 days)
- Reversibility of contrast induced nephropathy(15 days)
- Proportion of adverse events(15 days)
研究者
David Garcia Cinca
Clinical Research Manager
Hospital Clinic of Barcelona
研究点 (1)
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