Diuretic Treatment in High Risk Decompensated Advanced Heart Failure. Bolus Intermittent Versus Continuous Infusion of Furosemide: a Randomized Controlled Trial.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Freedom from congestion
研究概览
简要总结
Loop diuretics are the main therapy for decongestion of patients with advanced acute heart failure. However, these patients often develop diuretic-resistance or even diuretic-refractoriness. In order to overcome such resistance to diuretic, the clinician can increase the dose of furosemide, or change the way of administration (continuous infusion versus boluses) or associate a different class of diuretics (thiazide diuretics, K+-sparing diuretics) up to the addition of low doses of inotropic agents to improve renal perfusion. At the present time there is no evidence in literature in advanced acute heart failure patients about the superiority of the treatment with furosemide in continuous infusion or in intermittent boluses. The aim of the study was to evaluate the efficacy of furosemide in boluses versus continuous infusion in advanced acute 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, Care Provider)
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
- •Advanced heart failure
- •Systolic blood pressure ≤ 110 mmHg
- •Serum sodium ≤ 135 mEq/L
- •Left systolic ventricular insufficiency (FE < 35%) note for at least 6 months
- •Class NYHA III-IV despite medical treatment maximal
排除标准
- •Acute coronary syndrome
- •Shock cardiogenic
- •Chronic renal failure stage V
研究组 & 干预措施
Continuous infusion of loop diuretics
Furosemide continuous infusion: 125 or 250 mg die
干预措施: Loop Diuretics (Drug)
Intermittent infusion of loop diuretics
Furosemide bolus intermittent: 125 or 250 mg die
干预措施: Loop Diuretics (Drug)
结局指标
主要结局
Freedom from congestion
时间窗: 72 hours after randomization
次要结局
- Change in body weight(72 hours after randomization)
- Treatment failure(72 hours after randomization)
- Weight differences based on diuretic dose unity(72 hours after randomization)
- Worsening of renal function(72 hours after randomization)
- Worsening or persistent HF at 72 h(72 hours after randomization)
- Laboratory data variations in NTproBNP(72 hours after randomization)
研究者
Simone Frea
MD, Cardiologist
University of Turin, Italy