Impact of Hypertonic Saline Solution on Acute Decompensated Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Length of Hospital Stay
研究概览
简要总结
Acute decompensated heart failure (HF) is one of the most common cardiologic issues in emergency departments.
Loop diuretics have long been recognized as the key for the treatment of Acute Decompensated Heart Failure (ADHF).However, chronic treatment with diuretics may limit their response and deteriorates the renal function. The hypertonic saline solution (HSS) has been proposed in recent years as an adjunctive therapy for intravenous loop diuretics to improve or restore their initial pharmacological efficacy.
In this study the investigators will evaluate the effectiveness of HSS as an adjunct to i.v. furosemide in patients admitted for AHF with renal dysfunction
详细描述
In the era of the emergence of novel therapies for advanced Chronic Heart Failure , the use of HSS as a therapeutic adjunct to i.v. loop diuretics still needs to be explored on a larger scale, in particular in patients with renal dysfunction.
The objective of this study is: to evaluate the effectiveness of HSS as an adjunct to i.v. furose¬mide in patients admitted for AHF with renal dysfunction.
- Patients receive intravenous infusion of HSS (50ml of 10% NaCl) + Furosemide ( 250mg of furosemide) administered over one hour twice a day.
- Patients receive intravenous infusion of 5% Dextrose Solution (50ml of Dextrose 5%) + Furosemide (250mg of furosemide) administered over one hour twice a day.
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
- Single (Participant)
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
- •Patients with 18 years of age or older
- •ADHF with congestive symptoms, laboratory(BNP) and echocardiographic criteria
- •NYHA ≥II(New York Heart Association functional classification)
- •Creatinine clearance≤60ml/mn (MDRD) or level of creatinine >150 µg/ml)
- •BNP levels on admission ≥400 pg/mL
排除标准
- •age < 18 years
- •NYHA class < II
- •Patients with acute coronary syndrome, pulmonary thromboembolism, cardiac tamponade, pericarditis, those on dialysis; patients with chronic liver disease, pleuropneumonia, cerebral vascular disease, cancer, uncompensated diabetes, patients requiring pacemaker and concomitant other important comorbidity
- •Signs of hemodynamic instability, respiratory distress, coma
研究组 & 干预措施
Hypertonic Saline Solution
50 ml of intravenous Hypertonic Saline Solution over 1 hour + 250mg of IV furosemide over 1 hour
干预措施: Hypertonic Saline Solution (Drug)
5% Dextrose solution
50ml of 5% Dextrose solution over 1 hour + 250mg of IV furosemide over 1 hour
干预措施: Placebo (Drug)
结局指标
主要结局
Length of Hospital Stay
时间窗: 1 week
The period during which the patient is hospitalized
In-hospital mortality
时间窗: 1 week
Death occuring during hospitalization
Renal Function Impairement
时间窗: 1 week
Deterioration of renal function during hospital stay
Need for inotropic drugs
时间窗: 1 week
Hemodynamic instability requiring the introduction of inotropic drugs
次要结局
- 30 day Mortality(30 days)
- Need for Renal Replacement Therapy(1 week)
- Hospital Readmission(30 days)
研究者
Pr. Semir Nouira
Professor
University of Monastir