跳至主要内容
临床试验/NCT04062786
NCT04062786Unknown不适用

Postoperative Renal Failure in Cardiac Surgery PMSF-PVC Gradient Study

University Hospital, Strasbourg, France1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2019年2月21日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
130
试验地点
1
主要终点
Evolution of the gradient Pmsf (arm) -PVC

研究概览

简要总结

Acute renal failure is a frequent and severe postoperative complication of cardiac surgery performed under extracorporeal circulation.

It is an independent risk factor for mortality and significantly increases the length of hospital stay.

The origin of renal insufficiency after extracorporeal circulation is multifactorial (long duration of extracorporeal circulation, hemodynamic instability per and post-extracorporeal circulation, prolonged hypotension, transfusion ...).

Nevertheless, an entirely different pathophysiological mechanism, though not recent, is less often mentioned but shows renewed interest. This is the concept of renal venous congestion which may be responsible for impaired renal function in the absence of cardiac dysfunction. Based on Guyton's circulatory model, the investigators approach this systemic venous hypertension through the measurement of the Pmsf-PVC gradient.

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

  • age> 18 years
  • subject having signed an informed consent
  • scheduled heart surgery:
  • Valve replacement
  • Coronary artery bypass

排除标准

  • Any urgent surgery or redux
  • Severe preoperative chronic renal failure (stage III) defined by GFR <30ml / min
  • Existence of rhythm disorders (permanent ACFA) or serious cardiac conduction disorders, patients with Pacemaker
  • Preoperative alteration of left ventricular ejection fraction with LVEF <40%
  • Major haemodynamic instability with refractory shock defined by dobutamine ≥10μg / kg / min and / or norepinephrine ≥ 1μg / kg / min and / or epinephrine ≥ 0.2μg / kg / min.
  • Intra-aortic versus assisted pelvic balloon
  • Contraindication to femoral arterial catheterization
  • Subject under the protection of justice, subject under guardianship or under tutorship
  • Impossibility of giving the subject informed information (subject in emergency situation, difficulties in understanding the subject)

结局指标

主要结局

Evolution of the gradient Pmsf (arm) -PVC

时间窗: 24 hours

Monitor the evolution of the Pmsf (arm) -PVC gradient at H24 and compare this gradient between the two patient populations (with and without postoperative acute renal failure)

次要结局

未报告次要终点

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (1)

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