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临床试验/NCT03197051
NCT03197051已完成不适用

Impact of Perioperative Shedding of the Endothelial Glycocalyx on the Incidence of Postoperative Acute Kidney Injury in Patients Undergoing Valvular Heart Surgery.

Yonsei University1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2017年6月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
250
试验地点
1
主要终点
Acute kidney injury

研究概览

简要总结

Endothelial glycocalyx, the luminal structure of healthy vasculature, plays critical roles in regulation of inflammatory responses, vascular permeability, blood coagulation. It can be easily damaged by ischemia/reperfusion, hypoxemia, oxidative stress, endotoxin. Accordingly, the relationship between the shedding of endothelial glycocalyx and the prognosis of diseases such as diabetes mellitus, atherosclerosis, malignancy has been researched.

In cases of cardiac surgery, patients cannot help but be exposed to ischemia/reperfusion, oxidative stress which can damage endothelial glycocalyx. In this research, the investigators would like to discover the impact of perioperative shedding of the endothelial glycocalyx on the incidence of postoperative acute kidney injury in patients undergoing valvular heart surgery.

详细描述

Syndecan-1, Heparan sulfate serve as biomarkers of glycocalyx degradation. Both biomarkers will be measured 2 times, before the anesthetic induction, and immediately after weaning from cardiopulmonary bypass, during the valvular heart surgery.

Postoperative acute kidney injury up to postoperative 48 hours, Composite morbidity and mortality up to postoperative 30 days will be checked.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing valvular heart surgery (>20 years old)

排除标准

  • Emergency operation
  • Aorta surgery (Graft replacement of Total arch or Descending thoracic aorta)
  • Minimal invasive surgery
  • Chronic kidney disease (eGFR<30mL/min/1.73m2) / Dialysis history
  • Infective endocarditis
  • Malignancy
  • Patients who cannot give Informed consent (e.g. Illiterate, Foreigners)
  • Patients who are already enrolled to another study than can affect the results

结局指标

主要结局

Acute kidney injury

时间窗: Up to Postoperative 48 hours

Acute kidney injury is classified under KDIGO guideline. Stage I * Serum creatinine (Scr) : 1.5 to 1.9 times baseline or ≥26μmol/L (≥3.0mg/dL) increase * Urine output : \<0.5mL/kg/kr for 6\~12hrs Stage II * Serum creatinine (Scr) : 2.0 to 2.9 times baseline * Urine output : \<0.5mL/kg/hr for ≥12hrs Stage III * Serum creatinine (Scr) : 3.0 times baseline or ≥354μmol/L (≥4.0mg/dL) increase or Initiation for RRT * Urine output : \<0.3mL/kg/hr for ≥24hrs or Anuria for ≥12hrs

次要结局

  • Composite morbidity and mortality (by STS Major morbidity endpoint)(Up to postoperative 30 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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