External Validation of the VExUS Score for the Prediction of Acute Renal Failure in Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 119
- 试验地点
- 1
- 主要终点
- Association between the change in ultrasound data collected in the VExUS score and postoperative acute renal failure.
研究概览
简要总结
Acute renal failure is a frequent complication associated with significant morbidity and mortality in postoperative cardiac surgery.
The VExUS (Venous Excess UltraSound grading system) score was created to qualitatively assess this venous congestion, based on ultrasound data from patients obtained post operatively in cardiac surgery. These data included: inferior vena cava diameter, Doppler flow of the suprahepatic veins, portal trunk and renal veins.
This score is predictive of the onset of acute renal failure in the first 3 days after surgery.
The VExUS score has not been validated in an external and prospective way in cardiac surgery.
详细描述
Acute renal failure is a frequent complication associated with significant morbidity and mortality in postoperative cardiac surgery.
The pathophysiology in this context is complex, poorly understood and the causes are multiple: underlying nephropathy, intra- or postoperative haemodynamic instability, the use of an extracorporeal circulation, inflammation, etc.
One of the other possible etiologies is venous congestion. This may be due to volume overload and/or isolated global or right heart dysfunction.
Early treatment could prevent the onset of ARF or reduce its consequences, hence the importance of being able to predict its onset.
The VExUS (Venous Excess UltraSound grading system) score was created to qualitatively assess this venous congestion, based on ultrasound data from patients obtained post operatively in cardiac surgery. These data included: inferior vena cava diameter, Doppler flow of the suprahepatic veins, portal trunk and renal veins.
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
- 否
入选标准
- •Scheduled cardiac surgery
- •Affiliated to a social security system
排除标准
- •Emergency surgery
- •Chronic renal failure defined by a glomerular filtration rate of less than 30ml/min or dialysis.
- •renal transplant recipients
- •Cirrhosis and portal hypertension
- •Setting up a left ventricular assist device implantation
- •Patient under ECMO (ExtraCorporeal Membrane Oxygenation), intra-aortic balloon pump, or a mechanical circulatory support device such as IMPELLA
- •No available operator to perform ultrasound scans
- •Patients objecting to the use of their data in research
- •Subject under guardianship or subject deprived of freedom
- •Pregnant or breastfeeding women
- •Resume surgery within 48 hours of scheduled surgery
- •Lack of a trained operator to perform D+1 and D+2 ultrasound
结局指标
主要结局
Association between the change in ultrasound data collected in the VExUS score and postoperative acute renal failure.
时间窗: From date of randomization until date of post-operative acute renal failure (detected by daily creatininemia), assessed up to a variable period of time estimated to 2 weeks
Specificity of the VExUS score to predict an acute kidney failure will be evaluated
Association between the change in ultrasound data collected in the VExUS score and postoperative acute renal failure (defined by a creatininemia increase by 26.5 µmol/L in 48 hours).
时间窗: From date of randomization until date of post-operative acute renal failure (detected by daily creatininemia), assessed up to a variable period of time estimated to 2 weeks.
correlation between operator in term of VExUS staging (VExUS score will be assessed at day 1, 2 and 3 after the surgery, in intensive care unit.
次要结局
- Diagnostic performances of the VExUS Score for postoperative acute renal failure(3 days)
- Correlation between the VExUS score and a postoperative acute renal failure(3 days)
- Correlation between daily fluid balance and postoperative acute renal failure. If a statistical association is present, diagnostic performance (Sensitivity, Specificity, NPV, PPV) of the value(3 days)
- Correlation between an echocardiographic abnormality and postoperative acute renal failure. If a statistical association is present, diagnostic performance (Sensitivity, Specificity, NPV, PPV) of the value.(3 days)
- Correlation between VExUS score and the use of extra renal replacement therapy(From randomization until date of postoperative need of extra renal replacement therapy, assessed up to a variable period of time estimated to 2 weeks.)
- Correlation between renal arterial resistance index and postoperative acute renal failure. If a statistical association is present, diagnostic performance (Sensitivity, Specificity, NPV, PPV)(3 days)
- Correlation between central venous pressure (CVP) and postoperative acute renal failure. If a statistical association is present, diagnostic performance (Sensitivity, Specificity, NPV, PPV) of the value(3 days)
- Correlation between an isolated component of the VExUS score, echocardiography and postoperative acute renal failure. If a statistical association is present, diagnostic performance (Sensitivity, Specificity, NPV, PPV) of the value(3 days)
- Correlation between VExUS score and length of stay(From randomization until date of discharge, assessed up to a variable period of time estimated to 2 weeks.)
- Correlation between VExUS score and 1-month mortality(1 month after admission in intensive care)
- Correlation between renal venous impedance index and postoperative acute renal failure. If a statistical association is present, diagnostic performance (Sensitivity, Specificity, NPV, PPV)(3 days)