Congestion Assessment Using Venous Excess Ultrasound Score (VExUS) in Patients With Acute Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Development of acute kidney injury (AKI)
研究概览
简要总结
The importance of assessing venous congestion in heart failure patients is widely acknowledged, but its study is hampered by the lack of a practical evaluation tool. Venous excess ultrasound score (VExUS) is a promising noninvasive ultrasound-guided modality that can detect and objectify clinically significant organ congestion. VExUS congestion grading score was still not formally validated in patients with AHF, as there is limited data on its clinical application in this group of patients.
详细描述
It is currently unknown whether changes in systemic venous congestion, assessed by venous excess ultrasound score (VExUS), are associated with worsening renal function, reduced diuretic and natriuretic response, and poor prognosis in patients with acute decompensation of heart failure (AHF).
This prospective, observational, single-center study included patients admitted to the intensive care unit with AHF. At admission all patients undergo bedside Doppler ultrasound of inferior vena cava, hepatic, portal and renal veins to determine blood flow patterns. Congestion was graded with the VExUS score (grade 0, grade 1, grade 2, grade 3). Sodium concentration in a spot urine sample was assessed in 1 hour after first standard intravenous loop diuretic administration. The primary endpoint was the development of acute kidney injury (AKI), defined as oligoanuria (diuresis rate <0.5 ml/kg/hour for 6 hours) and an increase of serum creatinine >26 µmol/l within a 48-hour period or 50% from baseline creatinine within a week. The secondary endpoints were in-hospital mortality, change in spot urine sodium content <50 mmol/l and development of diuretics resistance (defined as the need to double starting dose of intravenous furosemide in 6 hours without adding a different class of diuretic agents).
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute decompensation of heart failure (diagnosis was based on the European Society of Cardiology (ESC) heart failure guidelines, with patients presenting with dyspnoea at rest or with minimal exertion and signs and symptoms of congestion (rales on chest auscultation, peripheral oedema, swelling of the cervical veins, hepatomegaly, ascites, hepatojugular reflux) and N-terminal pro-B-type natriuretic peptide (NT-proBNP) > 1000 pg/ml
排除标准
- •Chronic renal replacement therapy or glomerular filtration rate < 15 ml/min/1.73m 2 (chronic kidney disease Epidemiology Collaboration (CKD)-EPI)
- •Cirrhosis with portal hypertension
- •Acute myocardial infarction according to The Fourth Universal Definition of Myocardial infarction
- •Pulmonary embolism
- •Sepsis (according to The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3))
- •Endotracheal intubation at the time of admission
- •Pregnancy or breastfeeding
- •Aortic dissection
- •Active cancer
- •Neurological or mental disease during exacerbation
- •Refusal to sign an informed consent form, inadequate acoustic window
结局指标
主要结局
Development of acute kidney injury (AKI)
时间窗: During 7 days of hospital stay
Assessment of patient's serum creatinine at admission, in 48 hours, at day 7, and calculation of the amount of urine output in the first 6 h after the administration of a loop diuretic.
次要结局
- In-hospital mortality(During patient's hospital stay (up to 14 days))
- Development of diuretics resistance (defined as the need to double initial dose of intravenous furosemide in 6 hours without adding a different class of diuretic agents)(6 hours after first intravenous furosemide administration)
- Change in spot urine sodium content <50 mmol/l(1 hour after first standard intravenous loop diuretic administration after patient's admission.)