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临床试验/NCT01554345
NCT01554345Unknown2 期

Assessment of Preventive Effect of Vitamin E +Selenium on Acute Kidney Injury Through NGAL in Patients Undergoing Controlled Hypotension During Neurosurgery Operations

Tehran University of Medical Sciences2 个研究点 分布在 2 个国家目标入组 60 人开始时间: 2011年6月1日最近更新:
适应症
相关药物

试验速览

阶段
2 期
入组人数
60
试验地点
2
主要终点
increased amount of urinary or serum NGAL after controlled hypotension

研究概览

简要总结

The purpose of this study is to determine whether Kidney injury happens in controlled hypotension during brain operations by using Neutrophil Gelatinase Associated Lipocalin ELISA Kit and if so, does VitaminE+Selenium prevent it

详细描述

NGAL(Neutrophil Gelatinase Associated Lipocalin) is a 25KD protein which bounds with Gelatinase in Neutrophil granules.It is also expressed in epithelial cells of kidney tubules.NGAL increases in ischemic and toxic injuries of kidney. During controlled hypotension in brain operations injury to the kidneys might occur . This study is designed to assess this possibility and evaluate the effect of VitaminE+Selenium on prevention of this problem

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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

入选标准

  • All patients who are candidate for brain surgery under controlled hypotension

排除标准

  • Positive history of renal disease
  • Positive history of diabetes mellitus, CHF, HTN, Breast cancer, fever, leukocytosis

结局指标

主要结局

increased amount of urinary or serum NGAL after controlled hypotension

时间窗: from 2 hours to 24 hours after controlled hypotension

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

Zahed Hosein Khan

professor

Tehran University of Medical Sciences

研究点 (2)

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