Effect of Intravenous Sodium Chloride on Urinary Biomarkers for Measurement of Sodium- and Water Channel Activity in the Nephron in Healthy Subject an Patients With Chronic Kidney Disease. A Case Control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- urinary biomarkers
研究概览
简要总结
Patients with chronic kidney disease (CKD) have a defect in the tubular reabsorption of sodium, and therefore the ability to excrete a sodium load is diminished compared to healthy subjects.
Urinary biomarkers reflects the water- and sodium-channel activity in the kidney and may be measured after an infusion with hypertonic saline in CKD patients and healthy subjects.
详细描述
The fractional sodium excretion is elevated as high as 10-20% In patients with chronic kidney disease (CKD) Changes in the sodium intake results in a slower expansion and/or reduction in extracellular fluid in CKD patients.
Urinary biomarkers reflects the kidneys transport of sodium and water in the nephron.
Changes in the sodium-and water channel activity is induced by intervention with hypertonic Saline (3.0%) The change in sodium-and water channel activity is followed by change in extracellular and intracellular fluid compartments and the plasma concentration of vasoactive hormones.
The purpose of this study is to investigate the changes in urinary biomarkers (u-NKCC2, u-ENaC-gamma and u-AQP2), the activity of the sodium-and water channels, the extra- and intracellular fluid compartments and the plasma concentration of Vasoactive hormones in patients with CKD and in healthy subjects.
Subjects and patients are examined during one examination day. Four days prior to the examination day the subjects consume a standardized diet based on the amount of sodium and calories. On the examination day the subjects receive an infusion with hypertonic saline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy subjects
- •healthy males and females
- •age 18-70
- •BMI range 18,5-30,0 kg/m2
- •Patients with CKD
- •age 18-70
- •eGFR 15-60 ml/min
- •BMI range 18.5 - 30.0 kg/m2
排除标准
- •healthy subjects
- •hypertension (ie ambulatory BP >130 mmHg systolic or/and >80 mmHg diastolic)
- •history or clinical significant signs of heart, lung, liver, kidney, endocrine, brain or neoplastic disease.
- •alcohol abuse
- •drug abuse
- •pregnancy or nursing
- •blood donation within a month prior to examination
- •Medical treatment apart from oral contraception
- •Patients with chronic kidney disease
- •clinical significant signs of heart, lung, liver, endocrine, brain or neoplastic disease.
- •immunosuppressive medications
- •alcohol abuse
- •drug abuse
- •pregnancy or nursing
结局指标
主要结局
urinary biomarkers
时间窗: one day
Urinary epithelial sodium channels (ENaC), Sodium-potassium-2chloride transporters (NKCC) and aquaporin2 channels (AQP2) before, during and after fluid infusion
次要结局
- extra-and intracellular volume(6 hours)
- vaso active hormones(one day)
研究者
Erling Bjerregaard Pedersen
DMSc
Regional Hospital Holstebro