Readily Available Urinary Sodium Analysis in Patients With Acute Decompensated Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Urinary sodium excretion after 48 hours
研究概览
简要总结
The goal of this clinical trial is to compare physician-guided (SOC) versus nurse-led natriuresis-guided diuretic therapy in patients with acute decompensated heart failure (ADHF). The main questions it aims to answer are:
- difference in natriuresis and diuresis
- feasibility of the protocol.
Participants will be asked to gather two 24 h urine collections.
Researchers will compare SOC versus nurse-led diuretic titration to see if there is a difference in natriuresis after 48 hours.
详细描述
The EASY-HF study was a single-centre, randomized, open-label study comparing standard of care (SOC) diuretic management at the treating physician's discretion with a nurse-led natriuresis-guided protocol in patients with ADHF. A bedside sensor was used to measure the urinary sodium content.The primary endpoint was total natriuresis after 48 hours. Secondary endpoints included safety profile and user-friendliness of both the protocol and the point-of-care sensor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
All physicians were blinded for the spot urinary sodium measurements. Additionally, while urine was collected for the first 48 h in both groups, the analysis was only performed afterwards.
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
- •Older than 18 years
- •Provide written informed consent
- •Hospital admission with signs and symptoms of congestion warranting intravenous decongestive therapy
- •Congestion score of at least 2 based upon the presence of edema, pleural effusion, or ascites
- •N-terminal pro-B-type natriuretic peptide (NT-proBNP) level of at least 500 ng per litre (800 ng per litre in case of atrial fibrillation)
排除标准
- •Patients unable to collect a 48h-urine collection
- •Estimated GFR below 20 ml/min/1.73m^2
- •Concomitant diagnosis of an acute coronary syndrome
- •Need for inotropic or vasopressor support
- •Ventricular assist device
- •Renal replacement therapy
- •Treatment with intravenous loop diuretics > 80mg furosemide or an equivalence of another loop diuretic (40mg furosemide = 1mg bumetanide) during the index hospitalization and prior to randomization
结局指标
主要结局
Urinary sodium excretion after 48 hours
时间窗: 48 hours
Total natriuresis after 48 hours (mmol)
次要结局
- Urinary sodium excretion on daily base(24 hours)
- Achievement of decongestion(48 hours)
- Urinary output after 48 hours(48 hours)
- Urinary output on daily base(24 hours)