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临床试验/NCT04419662
NCT04419662已完成4 期

Evaluation of Patients After Cardiac Surgery: Novel Ultrasound Parameters for Quantification of Renal Perfusion & Analysis of Phenylephrines' Effect on Invasive Haemodynamics and Echocardiographic Measures

Aarhus University Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年5月25日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Renal arterial resistive index (RI).

研究概览

简要总结

To investigate the influence of PEEP (Positive end-expiratory pressure), changes in preload (patient position) and changes in afterload (phenylephrine) on ultrasound measures of renal perfusion in patients after uncomplicated cardiac surgery.

To investigate the effects of phenylephrine on both invasive measures of the systemic- and pulmonary circulation and, secondarily, to assess the induced changes in echocardiographic indices of left- and right ventricular systolic- and diastolic function.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

盲法说明

Ultrasound analysis is performed offline and details on participants and time of measurement are blinded for the person doing the analysis. The personnel responsible for obtaining data will not be blinded towards any of the interventions.

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 open elective cardiac surgery at the Department of Cardiothoracic & Vascular Surgery, Aarhus University Hospital.

排除标准

  • Insufficient ultrasonographic imaging of the kidneys
  • Known morphological kidney disease
  • Preoperative dialysis
  • Chronic atrial fibrillation
  • Planned mitral valve surgery

研究组 & 干预措施

All patients included

Experimental

干预措施: Phenylephrine (Drug)

All patients included

Experimental

干预措施: Combination of PEEP and positioning (Other)

结局指标

主要结局

Renal arterial resistive index (RI).

时间窗: 75 minutes

The ratio SVR/PVR (systemic vascular resistance/pulmonary vascular resistance)

时间窗: 75 minutes

次要结局

  • Transoesophageal measurement of left and right ventricular function 5(75 minutes)
  • Renal venous impedance index.(75 minutes)
  • Transoesophageal measurement of left and right ventricular function 1(75 minutes)
  • Transoesophageal measurement of left and right ventricular function 6(75 minutes)
  • Renal venous stasis index.(75 minutes)
  • Portal vein pulsatility fraction.(75 minutes)
  • Cardiac output(75 minutes)
  • Arterial blood pressure, central venous pressure, pulmonary blood pressure, pulmonary capillary wedge pressure.(75 minutes)
  • Transoesophageal measurement of left and right ventricular function 2(75 minutes)
  • Transoesophageal measurement of left and right ventricular function 3(75 minutes)
  • Transoesophageal measurement of left and right ventricular function 4(75 minutes)

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 (1)

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