A Normal Sodium Diet Preserves Serum Sodium Levels During Treatment of Acute Decompensated Heart Failure
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Failure; With Decompensation
- Sponsor
- University of Sao Paulo
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Serum sodium level at day 7
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
This study is design to assess two levels of dietary sodium intake in the treatment of patients with Acute Decompensated Heart Failure.
Detailed Description
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.
Investigators
Camila Godoy Fabricio
Master
University of Sao Paulo
Eligibility Criteria
Inclusion Criteria
- •Patients with Acute Decompensated Heart Failure diagnosis, filling the Framingham diagnostic criteria, hospitalized at campus Hospital das Clínicas of Ribeirão Preto.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Serum sodium level at day 7
Time Frame: 7 days
The difference of the absolute value of serum sodium between the groups in the final evaluation.
Secondary Outcomes
- 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)