Comparison of the Effectiveness of Bolus and Infusion Diuretic Therapy in the Management of Acute Heart Failure in Emergency Departments: a Randomised, Double-blind Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Diuresis
研究概览
简要总结
Acute decompensated heart failure (ADHF) is a clinical syndrome associated with high morbidity and mortality rates. Current guidelines emphasize the importance of oxygenation and diuresis in the management of ADHF. However, there is no clear recommendation regarding whether diuretic therapy should be administered as intermittent bolus dosing or continuous infusion. The aim of this study was to compare the early efficacy of bolus versus continuous infusion diuretic therapy in the emergency department management of ADHF. In this single-center, prospective, randomized, double-blind, parallel-group clinical trial, patients aged ≥18 years presenting with ADHF and without known chronic kidney disease were randomized in a 1:1 ratio to receive either intermittent bolus therapy or continuous infusion therapy. Allocation concealment was ensured using opaque sealed envelopes. To maintain blinding, simultaneous placebo-like administrations were performed in both groups. The primary endpoint was total urine output at 2 and 4 hours. Secondary endpoints included changes in the internal jugular vein collapsibility index (JVCI) at 2 and 4 hours. Tertiary end point was spot urinary sodium at 2 and 4 hours.
详细描述
Acute decompensated heart failure (ADHF) is a common cause of emergency department admission and is associated with significant morbidity and mortality. Intravenous loop diuretics remain the cornerstone of treatment for patients presenting with volume overload. However, the optimal method of administration-intermittent bolus versus continuous infusion-remains controversial.
Most randomized studies comparing these strategies have been conducted in hospitalized patients and have focused on outcomes measured over longer observation periods. Data evaluating the early response to diuretic therapy in the emergency department setting are limited.
This prospective, randomized, double-blind clinical study aimed to compare the early effects of intravenous bolus versus continuous infusion furosemide therapy in patients presenting to the emergency department with acute decompensated heart failure.
Eligible patients were randomly assigned to receive either intermittent intravenous bolus furosemide or continuous infusion furosemide. Blinding was achieved by administering placebo infusion or placebo bolus according to treatment allocation. The primary outcome of the study was cumulative urine output during the first four hours after treatment initiation. Secondary outcomes included changes in the internal jugular vein collapsibility index measured by bedside ultrasound. The tertiary outcome was the spot urinary sodium at 2nd and 4th hours of study The study also evaluated the potential role of internal jugular vein collapsibility index as a dynamic and non-invasive parameter for monitoring systemic congestion during early diuretic therapy in the emergency department.
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
Double Blind (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥18 years
- •Established diagnosis of heart failure
- •Presentation with acute decompensation meeting AHA/ACC Stage C-D criteria
- •New York Heart Association (NYHA) Class III-IV functional status at admission
排除标准
- •Known chronic kidney disease
- •Hemodynamic instability at presentation
- •Development of advanced airway requirement during follow-up
- •Requirement for emergent dialysis
研究组 & 干预措施
Bolus Group
Patients in this group received an intravenous bolus equivalent to 2.5 times their total daily oral diuretic dose in 10mL syringe. Blinding was ensured by administering 100 mL of intravenous continuous infusion normal saline as a placebo.
干预措施: Furosemide Bolus (Drug)
İnfusion Group
Patients in this group received an intravenous continious infusion equivalent to 2.5 times their total daily oral diuretic dose in 100mL saline bag. Blinding was ensured by administering 10 mL syringe of intravenous bolus normal saline as a placebo.
干预措施: Furosemide Continuous İnfusion (Drug)
结局指标
主要结局
Diuresis
时间窗: 2nd and 4th hours after administration of Furosemide
Total cumulative urine output
次要结局
- Juguler Venous Collapsibility Index Change(after administration of furosemide, 2nd and 4th hour)
研究者
Erdem Cevik
Professor
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey