Effect of Hydroxyethyl Starch on Renal Handling of Sodium and Water, Vasoactive Hormones,Biomarkers and the Circulatory System in Patients Undergoing Hip Replacement Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- u-NGAL
研究概览
简要总结
The purpose of this project is to investigate if hydroxyethyl starch (HES) is potential nephrotoxic and examine the effects on the circulation and kidneys during administration of HES during surgery.
详细描述
Hydroxyethyl starch (HES) is widely used in hospitals to maintain circulation in critically ill patients. In recent years studies have raised suspicion that HES is nephrotoxic. So far acute kidney injury has been diagnosed based on creatinine measurements, but new technology allows for earlier diagnosis using measurements of biomarkers in urine.
The purpose of this project is to investigate HES's potential toxicity and effects on the circulation and kidneys using measurements of biomarkers specific for toxicity and for the sodium/water balance in the urine and by measurements of vasoactive hormones in the blood after administration of HES 130/0.4
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Males and females
- •Indication for Arthroplasty of hip
排除标准
- •Blood donation within the last month
- •Lack of wish to participate
- •eGFR< 15ml/min
- •pregnancy or breast feeding
- •Need of NSAID
研究组 & 干预措施
Voluven (Hydroxyethyl starch 130/0,4)
Patients undergoing hip replacement surgery will receive either fluid therapy with active comparator (Voluven) or placebo (Sodium Chloride. Patients will receive minimum 7,5 ml/kg in the first hour of the surgery and 5 ml/kg in the subsequent hours.
干预措施: Voluven (Hydroxyethyl starch 130/0,4) (Drug)
Sodium Chloride 9 mg/ml
Patients undergoing hip replacement surgery will receive either fluid therapy with active comparator (Voluven) or placebo (Sodium Chloride. Patients will receive minimum 7,5 ml/kg in the first hour of the surgery and 5 ml/kg in the subsequent hours.
干预措施: Sodium Chloride 9 mg/ml (Drug)
结局指标
主要结局
u-NGAL
时间窗: 2-4 hours
The main objective is for the trial (only patients undergoing elective hip replacement surgery) to measure the effect of hydroxyethyl starch on u-NGAL, which is a biomarker of nephrotoxicity
次要结局
- u-Kim1, u-LFABP(2-4 hours)
- FENa, u-ENaCβ, CH2O, u-AQP2,u-NCC, u-NK2CC(2-4 hours)
- PRC, p-Ang-II, p -Aldo, p-ANP,P-GDP, p-AVP, p-Endot(2-4 hours)
- SBP, DBP, heartrate(2-4 hours)
研究者
Erling Bjerregaard Pedersen
Professor
Regional Hospital Holstebro