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Original Investigation |

Aggressive Fluid and Sodium Restriction in Acute Decompensated Heart Failure:  A Randomized Clinical Trial

Graziella Badin Aliti, RN, ScD; Eneida R. Rabelo, RN, ScD; Nadine Clausell, MD, PhD; Luís E. Rohde, MD, ScD; Andreia Biolo, MD, ScD; Luis Beck-da-Silva, MD, ScD
JAMA Intern Med. 2013;173(12):1058-1064. doi:10.1001/jamainternmed.2013.552.
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Importance The benefits of fluid and sodium restriction in patients hospitalized with acute decompensated heart failure (ADHF) are unclear.

Objective To compare the effects of a fluid-restricted (maximum fluid intake, 800 mL/d) and sodium-restricted (maximum dietary intake, 800 mg/d) diet (intervention group [IG]) vs a diet with no such restrictions (control group [CG]) on weight loss and clinical stability during a 3-day period in patients hospitalized with ADHF.

Design Randomized, parallel-group clinical trial with blinded outcome assessments.

Setting Emergency room, wards, and intensive care unit.

Participants Adult inpatients with ADHF, systolic dysfunction, and a length of stay of 36 hours or less.

Intervention Fluid restriction (maximum fluid intake, 800 mL/d) and additional sodium restriction (maximum dietary intake, 800 mg/d) were carried out until the seventh hospital day or, in patients whose length of stay was less than 7 days, until discharge. The CG received a standard hospital diet, with liberal fluid and sodium intake.

Main Outcomes and Measures Weight loss and clinical stability at 3-day assessment, daily perception of thirst, and readmissions within 30 days.

Results Seventy-five patients were enrolled (IG, 38; CG, 37). Most were male; ischemic heart disease was the predominant cause of heart failure (17 patients [23%]), and the mean (SD) left ventricular ejection fraction was 26% (8.7%). The groups were homogeneous in terms of baseline characteristics. Weight loss was similar in both groups (between-group difference in variation of 0.25 kg [95% CI, −1.95 to 2.45]; P = .82) as well as change in clinical congestion score (between-group difference in variation of 0.59 points [95% CI, −2.21 to 1.03]; P = .47) at 3 days. Thirst was significantly worse in the IG (5.1 [2.9]) than the CG (3.44 [2.0]) at the end of the study period (between-group difference, 1.66 points; time × group interaction; P = .01). There were no significant between-group differences in the readmission rate at 30 days (IG, 11 patients [29%]; CG, 7 patients [19%]; P = .41).

Conclusions and Relevance Aggressive fluid and sodium restriction has no effect on weight loss or clinical stability at 3 days and is associated with a significant increase in perceived thirst. We conclude that sodium and water restriction in patients admitted for ADHF are unnecessary.

Trial Registration clinicaltrials.gov Identifier: NCT01133236

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Figures

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Figure 1. Consolidated Standards for Reporting of Trials flowchart.

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Figure 2. Change in body weight from baseline to 3-day reassessment and from baseline to the end of the study period in the intervention and control groups. Significance was determined using the Mann-Whitney test. Data points indicate the mean values; whiskers indicate SD.

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Figure 3. Change in clinical congestion score from baseline to 3-day reassessment and from baseline to the end of the study period in the intervention and control groups. Significance was determined using the Mann-Whitney test. Data points indicate the mean values; whiskers indicate SD.

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Figure 4. Progression of perceived thirst during the study (time, P = .32; group, P = .25; time × group P = .01; by mixed-effects models). Data points indicate the mean values; whiskers indicate SD.

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The American Medical Association is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The AMA designates this journal-based CME activity for a maximum of 1 AMA PRA Category 1 CreditTM per course. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Physicians who complete the CME course and score at least 80% correct on the quiz are eligible for AMA PRA Category 1 CreditTM.
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