Randomized Clinical Trial to Assess the Effect of Fluid and Salt Restriction on the Management of Patients Hospitalized Due to Decompensated Heart Failure
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Hospital de Clinicas de Porto Alegre
- Enrollment
- 80
- Primary Endpoint
- Bodyweight loss
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
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.
Detailed Description
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
Investigators
Eneida Rejane Rabelo da Silva
Professor, PhD.
Hospital de Clinicas de Porto Alegre
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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).
Outcomes
Primary Outcomes
Bodyweight loss
Time Frame: 7 days
Daily weight on a digital scale
Clinical stability
Time Frame: Seven days.
Clinical assessment daily for 7 days.
Secondary Outcomes
- Health state evaluation.(30 days)
- Evaluation of thirst sensation.(Seven days)
- Re-hospitalizations.(30 days)