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临床试验/NCT03727204
NCT03727204已完成不适用

Acute Kidney Injury After Cardiac Surgery: Novel Ultrasound Techniques for Prediction of Acute Kidney Injury

Aarhus University Hospital2 个研究点 分布在 2 个国家目标入组 150 人开始时间: 2018年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
150
试验地点
2
主要终点
The association between the kidney venous ultrasonography flow pattern category on the 1st postoperative day and acute kidney injury (AKI) on the 4th postoperative day.

研究概览

简要总结

Acute Kidney Injury (AKI) is a frequent and important complication to cardiac surgery. This study will evaluate the diagnostic ability of ultrasonographic measures of blood flow in kidneys and liver in predicting AKI after cardiac surgery.

详细描述

Acute Kidney Injury (AKI) is a frequent and important complication to cardiac surgery. The pathophysiology is multifactorial, but renal functions in this setting is determined by a complex interplay between renal perfusion, fluid status, cardiac output, mean arterial pressure and back pressure to venous outflow.

Renal perfusion may be quantified with novel ultrasound techniques. Ultrasonography of the kidney and renal vasculature allows for assessment of renal afferent flow and renal venous flow and, together with venous flow patterns of the portal vein and liver veins, may identify patients in risk of AKI.

The study is observational and will describe the diagnostic accuracy of the ultrasound measures in predicting postoperative AKI. Patients will be examined with ultrasound of kidney and liver flow along with echocardiography on on the day before surgery and on the 1st and 4th. In addition, patients are followed with markers of kidney function, fluid balance and invasive measures of mean arterial pressure and central venous pressure.

研究设计

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

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

  • All patients ≥ 18 years
  • Scheduled for on-pump cardiac surgery
  • Oral and written consent
  • 1 of the following risk factors for development of postoperative AKI may be included:
  • age > 70 years;
  • NYHA (New York Heart Association) 3+4;
  • Insulin dependent diabetes;
  • Glomerular filtration rate < 60 ml/min/1,73 m2;
  • Ejection fraction < 35;
  • Combined CABG and valve surgery;
  • Any valve surgery except isolated aortic-valve surgery;
  • Redo surgery;
  • Endocarditis;
  • Peripheral vascular disease.

排除标准

  • Insufficient ultrasonographic imaging of the kidneys;
  • Known morphological kidney disease;
  • Preoperative dialysis;
  • Prior participation in the study.

结局指标

主要结局

The association between the kidney venous ultrasonography flow pattern category on the 1st postoperative day and acute kidney injury (AKI) on the 4th postoperative day.

时间窗: 4 days

The flow pattern is grouped as either continuous, biphasic or monophasic based on the appearance.The final analysis will possibly include other flow categories. AKI is defined by the 2012 Kidney Disease: Improving Global Outcomes (KDIGO) criteria and graded in four stages from no AKI to stage 1-3 AKI based on serum creatinin change and/or changes in urine output, with stage 3 being the worst stage.

次要结局

  • Correlation between changes in organ-specific flow measurements and the corresponding biomarkers.(1 month)
  • Diastolic dysfunction and AKI(1 month)
  • Establishment of the most optimal organ specific cut-off values and the development of AKI.(1 month)
  • Fluid balance and AKI(1 month)
  • Organ-specific flow measures and mortality(1 month)
  • Organ-specific flow measures and and time of stay in ICU and hospital(1 month)

研究者

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

Johan Fridolf Hermansen

Principal Investigator

Aarhus University Hospital

研究点 (2)

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