A Normal Sodium Diet Preserves Serum Sodium Levels During Treatment of Acute Decompensated Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Serum sodium level at day 7
研究概览
简要总结
This study is design to assess two levels of dietary sodium intake in the treatment of patients with Acute Decompensated Heart Failure.
详细描述
This study aim at assessing the effect of two levels of dietary sodium intake during seven days in hospitalized patients with Acute Decompensated Heart Failure. It is a prospective cohort, randomized, with blinded intervention groups: low sodium diet (the patients will receive 3 g/day of dietary sodium intake), and normal sodium diet (patients will receive 7 g/day of dietary sodium intake). Besides that, both groups will be submitted to a fluid intake limited to 1000 ml/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
- Triple (Care Provider, Investigator, 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 with Acute Decompensated Heart Failure diagnosis, filling the Framingham diagnostic criteria, hospitalized at campus Hospital das Clínicas of Ribeirão Preto.
排除标准
- •Creatinine clearance <30 ml / min / 1.73 m²;
- •Acute coronary syndrome;
- •Dementia;
- •Severe cognitive impairment;
- •Decompensated diabetes mellitus;
- •Severe liver disease;
- •Septic shock or with clinical signs of sepsis;
- •Chronic renal parenchymal disease prior to the start of the study;
- •ADHF secondary to acute renal failure;
- •Nutritional disorders or those who are unable to take oral intake because of vomiting, dysphagia or gastroenteritis.
研究组 & 干预措施
Low sodium diet
22 patients were randomized to receive 3 g/day of dietary sodium chloride and a limit of fluid intake of 1000 ml/day.
干预措施: Low sodium diet (Other)
Normal sodium diet
22 patients were randomized to receive 7 g/day of dietary sodium chloride and a limit of fluid intake of 1000 ml/day.
干预措施: Normal sodium diet (Other)
结局指标
主要结局
Serum sodium level at day 7
时间窗: 7 days
The difference of the absolute value of serum sodium between the groups in the final evaluation.
次要结局
- Occurrence of hyponatremia(on day 7)
- Diuretic dosage and other drugs to ADHF during intervention period(7 days)
- Change in serum levels of creatinine(7 days)
- Proportion of patients exhibiting worsening renal function (defined as increased serum creatinine> 0,3 mg / dL)(7 days)
- Rate of mortality after discharge(30 days)
- Change in body weight(7 days)
- Change in heart rate(7 days)
- Change in dyspnea sense(7 days)
- Change in well-being sense(7 days)
- Change in serum levels of NT-proBNP(7 days)
- Change in systolic, diastolic and mean blood pressure(7 days)
- Rate of hospital readmission(30 days)
研究者
Camila Godoy Fabricio
Master
University of Sao Paulo