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临床试验/NCT01486550
NCT01486550终止4 期

Effect of Hydroxyethyl Starch on Renal Handling of Salt and Water, Blood Pressure-regulating Hormones, Proteins and Circulatory System of Patients Undergoing Kidney Removal by Keyhole Surgery

Regional Hospital Holstebro1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2011年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
发起方
入组人数
14
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

入选标准

  • Age > 18 years
  • Males and females
  • Indication for laparoscopic nephrectomy

排除标准

  • Blood donation within the last month
  • Lack of wish to participate
  • eGFR< 15ml/min
  • Pregnancy or breast feeding

研究组 & 干预措施

Voluven (Hydroxyethyl starch 130/0,4)

Active Comparator

Patients undergoing laparoscopic nephrectomy will receive either fluid therapy with active comparator (Voluven) or placebo (Sodium Chloride)

干预措施: Voluven (Hydroxyethyl starch 130/0,4) (Drug)

Sodium Chloride 9mg/ml

Placebo Comparator

Patients undergoing laparoscopic nephrectomy will receive either fluid therapy with active comparator (Voluven) or placebo (Sodium Chloride)

干预措施: Sodium Chloride 9mg/ml (Drug)

结局指标

主要结局

u-NGAL

时间窗: 2-4 hours

The main objective for the trial(only patients undergoing elective laparoscopic nephrectomy) is to measure the effect of hydroxyethyl starch on u-NGAL, which is a biomarker of nephrotoxicity

次要结局

  • FENa, u-ENaCβ, CH2O, u-AQP2,u-NCC, u-NK2CC(2-4 hours)
  • u-Kim1 and u-LFABP(2-4 hours)
  • PRC, p-Ang-II, p -Aldo, p-ANP,P-GDP, p-AVP, p-Endothelin(2-4 hours)
  • SBP, DBP, heartrate(2-4 hours)

研究者

发起方
Regional Hospital Holstebro
申办方类型
Other
责任方
Principal Investigator
主要研究者

Erling Bjerregaard Pedersen

Professor

Regional Hospital Holstebro

研究点 (1)

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