Fluid and Salt Restriction in Decompensated Heart Failure Patients

Randomized Clinical Trial to Assess the Effect of Fluid and Salt Restriction on the Management of Patients Hospitalized Due to Decompensated Heart Failure

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Dietary supplement: Salt and fluid restriction

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Salt and Fluid; Intervention: Fluid 800 Ml and Salt 2 g per day Control: FLuid and Salt Free	Dietary supplement: Salt and fluid restriction; I: Intervention Prescription of low-sodium diet with additional 2 g of sodium and water restriction to 800 mL/day. II: Control Prescription without sodium and fluid restriction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bodyweight loss	Daily weight on a digital scale	7 days
Clinical stability	Clinical assessment daily for 7 days.	Seven days.

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Investigators: Principal Investigator: Luis B Silva-Neto, MD, ScD, Post Graduated Program of Federal University Program

Publications and helpful links

General Publications

• Aliti GB, Rabelo ER, Clausell N, Rohde LE, Biolo A, Beck-da-Silva L. Aggressive fluid and sodium restriction in acute decompensated heart failure: a randomized clinical trial. JAMA Intern Med. 2013 Jun 24;173(12):1058-64. doi: 10.1001/jamainternmed.2013.552.

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: November 9, 2009
• First Submitted That Met QC Criteria: May 27, 2010
• First Posted (Estimate): May 28, 2010

Study Record Updates

• Last Update Posted (Estimate): January 3, 2014
• Last Update Submitted That Met QC Criteria: December 31, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Heart Failure; Fluid restriction; Salt restriction; Congestion
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: UFRGS and HCPA 09117