Randomized Clinical Trial to Assess the Effect of Fluid and Salt Restriction on the Management of Patients Hospitalized Due to Decompensated Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 主要终点
- Bodyweight loss
研究概览
简要总结
The non-pharmacological measures that are widely practiced and recommended for HF patients, such as salt and water restriction, specially at moments of disease decompensation, still lack clearer evidence of their therapeutic effect.
详细描述
Heart Failure Clinics, healthcare structures formed by a multidisciplinary team specialized in the disease, have demonstrated to provide benefits to patients through multiple non-pharmacological interventions, among them fluid and salt restriction. Sodium restriction has a class I recommendation and evidence level C, that is, general agreement that the intervention is beneficial, useful and effective, evidenced by consensus, expert opinion, small studies, retrospective studies or registries. Sodium restriction becomes even more controversial when we consider evidence suggesting the benefit of non-salt restriction or treatments with salt administration, in the form of hypertonic solutions. In face of literature evidence not showing conclusive results about the benefit of sodium and fluid restriction, we designed this study in order to assess the effect of fluid and salt restriction on the management of patients hospitalized due to 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
- Single (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
- 否
入选标准
- •Patients of both sexes, with age equal to or above 18 years, diagnosed with decompensated HR (systolic dysfunction), according to the Boston Criteria (score > 8 points), who agree to participate in the study and sign an informed consent form.
排除标准
- •Patients presenting with endogenous creatinine clearance (ECC) values lower than or equal to 50-60 mL/min (obtained by the Cockcroft-Gault equation) at hospital admission, cardiogenic shock, survival compromised by another evolving disease, those with difficulty complying with treatment (dementia, cognitive deficit).
研究组 & 干预措施
Salt and Fluid
Intervention: Fluid 800 Ml and Salt 2 g per day Control: FLuid and Salt Free
干预措施: Salt and fluid restriction (Dietary Supplement)
结局指标
主要结局
Bodyweight loss
时间窗: 7 days
Daily weight on a digital scale
Clinical stability
时间窗: Seven days.
Clinical assessment daily for 7 days.
次要结局
- Health state evaluation.(30 days)
- Evaluation of thirst sensation.(Seven days)
- Re-hospitalizations.(30 days)
研究者
Eneida Rejane Rabelo da Silva
Professor, PhD.
Hospital de Clinicas de Porto Alegre