Hypertonic Saline Solution in Decompensated Heart Failure
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Occurrence of renal disfunction
研究概览
简要总结
Patients with decompensated heart failure have high rates of mortality and morbidity despite recent improvements in diagnosis and treatment. Some aspects of their presentation such as renal failure, hyponatremia and congestive phenomena have received special attention, as they are associated with worse prognosis. The infusion of hypertonic saline solution has been tested in different conditions of cardiovascular collapse. Current evidence indicates that the infusion of hypertonic solution in heart failure patients can provide clinical and haemodynamic improvement. The investigators are testing the hypothesis that the infusion of hypertonic solution in association with diuretics may prevent the occurrence of renal dysfunction 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
- Triple (Participant, Care Provider, 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
- •Age over 18 years old
- •Heart failure according to Framingham criteria
- •Episode of acute decompensation,with need of in-hospital treatment
- •Presence of congestive phenomena
排除标准
- •Patient denial
- •Left-ventricle ejection fraction over 0,4, as measure by transthoracic echocardiography
- •Rheumatic disease
- •Restrictive cardiomyopathy
- •Alcohol abuse
- •Chronic obstructive pulmonary disease
- •Pulmonary embolism during the last 6 months
- •Surgical procedures or acute illness during the last 30 days
- •Chronic or acute infection
- •Any other circumstance that may hamper patient prognosis for the next 6 months
- •Serum creatine over 3.0mg/dL
- •Serum potassium over 5.5 mEqs/L
- •Any specific condition associated to the acute episode of decompensation, such as new onset cardiac arrhythmias, heart ischemia, infection, etc.
研究组 & 干预措施
A
Group of patients that will receive hypertonic saline solution (NaCl 7,5%)
干预措施: NaCl 7,5% (Hypertonic Saline Solution) (Drug)
B
Group of patients that will receive placebo
干预措施: NaCl 0,9% (Drug)
结局指标
主要结局
Occurrence of renal disfunction
时间窗: During hospital admission
次要结局
- Improvement of hyponatremia(During hospital admission)
- Improvement of congestive phenomena(During hospital admission)
研究者
Edimar Alcides Bocchi
Heart Failure Team Director
University of Sao Paulo