The Effect of 0,9% NaCl on the Kidney Function, Vasoactive Hormones, Biomarkers and Glycosaminglycanes in Plasma in Patients Operated on for Primary Hiparthrosis
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Urinary excretion of Neutrophil gelatinase-associated lipocalin
研究概览
简要总结
The purpose of this study is to determine if chloride is nephrotoxic using 0,9% saline versus Plasma-Lytein in patients having primary hip replacement surgery. The outcome is found measuring bio markers, vasoactive hormones and salt regulation. And to measure syndecan as a marker for glycocalyx degradation.
详细描述
Hypothesis:
Chloride has a nephrotoxic effect, which can be shown partially by measuring bio markers for tubular injury in urine, partially by the changes in tubular transport of sodium and water in different parts of the nephron. This can be demonstrated using isotone sodium solutions with a lower chloride concentration in this study plasma-lyte versus normal isotone saline.
Klorid has a toxic effect on the glycocalyx layer and leads to a rise in syndecan 1 and simultaneously a change in Salt Blood Test either by a direct simulation and ANP levels in plasma or as a consequence of the hyperchloremic acidosis. This can be demonstrated using isotone sodium solutions with a lower chloride concentration in this study plasma-lyte versus normal isotone saline.
Purpose:
The purpose is to observe changes in bio markers, vasoactive hormones and salt regulation in patients randomized to either 0,9% saline or plasma-lyte undergoing primary uncemented hip replacement surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Indication for uncemented primary hiparthroplasty
- •age < 60
排除标准
- •Blooddonation or transfusion during the last month
- •Not willing to participate
- •estimated GFR below 30ml/min
- •type 1 diabetes
研究组 & 干预措施
plasma-lyte
Continuous 1 hour infusion of plasma-lyte 15 micrograms/kg/hour for the first hour then 5 micrograms/kg/hour + amount needet for blood replacement
干预措施: Plasma-lyte (Drug)
0,9% saline
Continuous 1 hour infusion of 0,9% saline15 micrograms/kg/hour for the first hour then 5 micrograms/kg/hour + amount needet for blood replacement
干预措施: 0,9% saline (Drug)
结局指标
主要结局
Urinary excretion of Neutrophil gelatinase-associated lipocalin
时间窗: two days
次要结局
- Urinary excretion of Kidney Injury Molecule(two days)
- Plasma concentration of angiotensin 2(two days)
- Plasma concentration of atrial natriuretic peptide (ANP)(two days)
- Plasma concentration of brain natriuretic peptide (BNP)(two days)
- Plasma osmolarity(two days)
- plasma Syndecan-1(two days)
- Urinary excretion of epithelial sodium channels(two days)
- Urinary excretion of Fatty acid-binding protein(two days)
- Plasma concentration of chloride(two days)
- plasma renin concentration(two days)
- Urinary excretion of cyclic guanosine monophosphate(two days)
- Plasma concentration of vasopressin (AVP, ADH)(two days)
- Free water clearance(two days)
- Plasma concentration of albumin(two days)
- Plasma concentration of sodium(two days)
- Urinary excretion of chloride(two days)
- Urinary excretion of potassium(two days)
- Fractional urinary sodium excretion(two days)
- Urinary excretion of albumin(two days)
- Urinary excretion of water channels(two days)
- Plasma concentration of aldosterone(two days)
- Plasma concentration of cyclic guanosine monophosphate (cGMP)(two days)
- Plasma concentration of endothelin(two days)
- Plasma concentration of creatinine(two days)
- pH(two days)
- Plasma concentration of potassium(two days)
- Urinary excretion of creatinine(two days)
- Urinary excretion of sodium(two days)
- Urinary osmolarity(two days)
- Urinary excretion of sodium-chloride symporter(two days)
- pulse(two days)
- middle arterial pressure(two days)
研究者
Erling Bjerregaard Pedersen
Professor, MD
Regional Hospital Holstebro