Serum Neutrophil Gelatinase Associated Lipocalin (NGAL) Levels in Hemodialysis (HD) Patients; Relation to Iron Status, Hemodialysis, and Intravenous (IV) Iron Administration
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- CRP (C-Reactive Protein) and AOPP (Advanced Oxidative Protein Products) Levels
研究概览
简要总结
The purpose of this study is to assess changes in serum levels of the siderophore binding protein NGAL by hemodialysis without and with intravenous iron administration
详细描述
Serum and urine levels of the siderophore binding protein neutrophil gelatinase associated lipocalin (NGAL) are increased in a number of renal diseases, but has not been evaluated yet in dialysis patients. Since NGAL is suggested to be related to inflammatory processes and iron homeostasis, which are a major problem in dialysis patients, this study aims to assess the relation of serum NGAL levels in hemodialysis (HD) patients to iron status, inflammation, hemodialysis and intravenous(IV) iron administration. Our hypothesis is that serum NGAL levels in HD patients are related to iron status and inflammation and may change following hemodialysis and/or acute or chronic IV iron administration.
The Specific aims are:
- To assess the relations between basal serum NGAL levels to iron, dialysis, and inflammation related parameters.
- To assess the effect of HD on serum NGAL levels and their relation with with iron, dialysis and inflammation related parameters.
- To assess the effects of weekly 100 mg IV iron in the first hour of HD on serum NGAL levels, and the relation of pre IV iron serum NGAL levels with iron, oxidative stress and inflammation related parameters. These assessments will be performed in the first weekly HD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 88 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic hemodialysis patients
排除标准
- •Acute disease (infection, thrombosis, ischemia, bleeding)
- •Hepatitis B, Hepatitis C or HIV
- •Intravenous iron administration or packed red cell transfusion in the last 4 weeks prior to the study
研究组 & 干预措施
Iron Saccharate (Venofer)
IV Iron Saccharate (Venofer)100 mg
干预措施: Iron Saccharate (Venofer) (Drug)
结局指标
主要结局
CRP (C-Reactive Protein) and AOPP (Advanced Oxidative Protein Products) Levels
时间窗: To assess the effects of 100 mg IV iron in the first hour of the first weekly HD on the relation of pre IV iron serum NGAL levels with oxidative stress and inflammation related parameters.
次要结局
未报告次要终点
研究者
David Tovbin
Dr David Tovbin, Department of Nephrology
Soroka University Medical Center