NCT06036914已完成2 期
Ultra High Dose Diuretic Strategy for Management of Acute Decompensated Heart Failure - A Randomized, Double-Blind Pilot Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Urine Output
研究概览
简要总结
The purpose of this study is to determine the safety and effectiveness of ultrahigh dose diuretics compared to standard dose diuretics over 24 hours in patients with decompensated heart failure.
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, Investigator)
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
- •Diagnosis of decompensated heart failure receiving intravenous diuretics
- •Ability to provide informed consent
排除标准
- •Patients on home inotrope medications
- •Patients with Chronic Kidney disease stage V and end stage renal failure on dialysis
- •Patients lacking the capacity to consent for themselves
- •Known pregnancy or breastfeeding mothers
- •Complex congenital heart disease
- •Allergy to furosemide or bumetanide
- •Respiratory failure requiring non-invasive ventilation (CPAP/BiPAP) or invasive mechanical ventilatory support at the time of randomization
- •Hypotension with systolic blood pressure <80 mm Hg at the time of randomization
- •Acute coronary syndrome
- •Sustained Ventricular tachycardia requiring treatment in the last 48 hours
- •Patients weighing ≤ 40 kg
研究组 & 干预措施
Ultra-high dose diuretic group
Experimental
Subjects with decompensated heart failure requiring hospitalization will receive IV bumetanide.
干预措施: Bumetanide (Drug)
Standard dose diuretic group
Active Comparator
Subjects with decompensated heart failure requiring hospitalization will receive IV furosemide.
干预措施: Furosemide (Drug)
结局指标
主要结局
Urine Output
时间窗: 24 hours
The total volume of urine produced in milliliters (mL) over 24 hours after initiation of intravenous diuretic.
次要结局
- Change in NT-proBNP(Baseline, 24 hours)
- Change in Peripheral Vein Pressure(Baseline, 24 hours)
- Change in Body Weight(Baseline, 24 hours)
- Change in Urine Sodium Excretion(Baseline, 24 hours)
- Change in Cardiac Output(Baseline, 24 hours)
- Change in E/e'(Baseline, 24 hours)
- Change in Apnea-hypopnea Index(Baseline, 24 hours)
- Change in Iohexol Glomerular Filtration Rate (GFR)(Baseline, 24 hours)
- Change in Estimated Right Ventricular (RV) Systolic Pressure(Baseline, 24 hours)
- Change in Right Atrial (RA) Pressure(Baseline, 24 hours)
- Change in Left Atrial (LA) Strain(Baseline, 24 hours)
- Change in Left Ventricular (LV) Global Longitudinal Strain(Baseline, 24 hours)
- Change in Right Ventricular (RV) Global Longitudinal Strain(Baseline, 24 hours)
研究者
研究点 (1)
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