Fluid and Salt Restriction in Decompensated Heart Failure Patients

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Dietary Supplement: Salt and fluid restriction

• Registration Number: NCT01133236
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

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

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-11-09
• Study First Submitted QC: 2010-05-27
• Study First Posted: 2010-05-28
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-31
• Last Update Posted: 2014-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Salt and Fluid	Salt and fluid restriction	Intervention: Fluid 800 Ml and Salt 2 g per day Control: FLuid and Salt Free

Primary Outcome Measures

Name	Time	Method
Bodyweight loss	7 days	Daily weight on a digital scale
Clinical stability	Seven days.	Clinical assessment daily for 7 days.

Secondary Outcome Measures

Name	Time	Method
Health state evaluation.	30 days	Evaluation of health state using the Euro-QOL 5D for 30 days after the 7th day of clinical stability assessment.
Evaluation of thirst sensation.	Seven days	Evaluation of thirst score on the Thirst Scale, daily for seven days.
Re-hospitalizations.	30 days	Medical records assessed for 30 days after the 7th day of clinical stability assessment.