跳至主要内容
临床试验/NCT02396901
NCT02396901Unknown不适用

Goal Direct Therapy to Prevent Acute Kidney Injury After Cardiac Surgery

University of Sao Paulo0 个研究点目标入组 214 人开始时间: 2015年4月最近更新:
适应症

试验速览

阶段
不适用
入组人数
214
主要终点
Acute Kidney Injury

研究概览

简要总结

This is an randomised controlled trial to investigate an strategy based in a protocol in prevention of acute kidney injury after cardiac surgery.

详细描述

This is a prospective, randomized controlled trial to assess the influence of use of angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARB) in the development of the Acute Kidney Injury in the postoperative period of cardiac surgery. Patients undergoing cardiac surgery at the Heart Institute (InCor) - Brazil, will be randomized and in accordance with a list of random numbers, generated by a computer program, will be allocated in one of the groups (GDT or standard).

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

  • Cardiac surgery with Cardiopulmonary Bypass (CPB); Age greater than 18 years; Chronic kidney disease stages 3 and 4 (GFR less than 60 mL/min and greater than 15 mL/min); Sign the informed consent form.

排除标准

  • Chronic renal insufficiency (GFR less than 15 mL/min); Heart surgery without CPB; Aortic procedures; Heart transplant or congenital heart disease; Prior use of Intra-Aortic Balloon Pump; Decompensated heart failure; Participation in other research protocol.

结局指标

主要结局

Acute Kidney Injury

时间窗: Within 48h after cardiac surgery

Development of acute kidney injury according to AKIN (Acute Kidney Injury Network) criterion.

次要结局

  • Serious clinical complications(For 28 days)

研究者

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

Eduesley Santana Santos

RN, Ph.D

University of Sao Paulo

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