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临床试验/NCT04890860
NCT04890860已完成不适用

Detection of Right Ventricular Dysfunction by Portal Vein Doppler After Cardiac Surgery

CMC Ambroise Paré2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2021年6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
70
试验地点
2
主要终点
Right ventricular failure

研究概览

简要总结

Right ventricular (RV) failure after cardiac surgery is associated with morbidity and mortality, but is hard to diagnose with conventional echocardiographic means. RV dysfunction may be associated with hepatic congestion, which may have an effect on portal veinous flow, but this has not been extensively. The investigators aimed determine whether an increased pulsatility in the portal venous flow was associated with RV dysfunction, after cardiac surgery at risk of RV dysfunction: mitral and tricuspid valve procedures.

详细描述

In cardiac surgical patients, RV dysfunction is associated with organ hypoperfusion and venous congestion leading to increased morbidity and mortality.

Non-invasive methods used to assess RV function are 2D-echocardiographic measurement of tricuspid annular plane systolic excursion (TAPSE), RV ejection fraction (EF), RV fractional area change (FAC), 3D assessment of RV function, tissue Doppler assessment of velocities, and magnetic resonance imaging (MRI). Though MRI is the gold standard method to assess RV function, it cannot be used in the perioperative period.

In the present prospective observational study, The investigators investigated the association between the pattern of portal venous flow and RV function as assessed by echocardiography in the postoperative period.

研究设计

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

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

  • More than 18 years old
  • Ability to provide an informed consent
  • Planned mitral and / or tricuspid valve surgery under cardiopulmonary bypass.

排除标准

  • Insufficient echogenicity

结局指标

主要结局

Right ventricular failure

时间窗: First 24 hours post cardiac surgery

1. systolic dysfunction (TAPSE below 16 mm or S wave below 9.5 cm/s) 2. RV fractional area change below 35% 3. End-diastole diameter ratio between RV and left ventricle \> 0.6 4. Ratio between S and D wave or inverse D wave in supra-hepatic veins

Portal flow measured by Doppler

时间窗: First 24 hours post cardiac surgery

flow pulsatility is assessed with the formula = 100 x (Vmax-Vmin)/Vmax. Time frame: First 24 hours post cardiac surgery

次要结局

  • Concordance of pulsatile flow assessment(First 24 hours post cardiac surgery)
  • Concordance of RV dysfunction measurements(First 24 hours post cardiac surgery)
  • Preoperative RV dysfunction(30 days before cardiac surgery)
  • Acute kidney injury(one week after surgery)
  • Cholestasis(one week after surgery)
  • Echocardiographic acquisition(First 24 hours post cardiac surgery)

研究者

发起方
CMC Ambroise Paré
申办方类型
Other
责任方
Sponsor

研究点 (2)

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