Fluid and Salt Restriction in Decompensated Heart Failure Patients
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Salt and fluid restriction
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Salt restriction, Fluid restriction, Congestion, Heart Failure
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).
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Salt and Fluid
Arm Description
Intervention: Fluid 800 Ml and Salt 2 g per day Control: FLuid and Salt Free
Outcomes
Primary Outcome Measures
Bodyweight loss
Daily weight on a digital scale
Clinical stability
Clinical assessment daily for 7 days.
Secondary Outcome Measures
Health state evaluation.
Evaluation of health state using the Euro-QOL 5D for 30 days after the 7th day of clinical stability assessment.
Evaluation of thirst sensation.
Evaluation of thirst score on the Thirst Scale, daily for seven days.
Re-hospitalizations.
Medical records assessed for 30 days after the 7th day of clinical stability assessment.
Full Information
NCT ID
NCT01133236
First Posted
November 9, 2009
Last Updated
December 31, 2013
Sponsor
Hospital de Clinicas de Porto Alegre
1. Study Identification
Unique Protocol Identification Number
NCT01133236
Brief Title
Fluid and Salt Restriction in Decompensated Heart Failure Patients
Official Title
Randomized Clinical Trial to Assess the Effect of Fluid and Salt Restriction on the Management of Patients Hospitalized Due to Decompensated Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Salt restriction, Fluid restriction, Congestion, Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Salt and Fluid
Arm Type
Experimental
Arm Description
Intervention: Fluid 800 Ml and Salt 2 g per day Control: FLuid and Salt Free
Intervention Type
Dietary Supplement
Intervention Name(s)
Salt and fluid restriction
Intervention Description
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.
Primary Outcome Measure Information:
Title
Bodyweight loss
Description
Daily weight on a digital scale
Time Frame
7 days
Title
Clinical stability
Description
Clinical assessment daily for 7 days.
Time Frame
Seven days.
Secondary Outcome Measure Information:
Title
Health state evaluation.
Description
Evaluation of health state using the Euro-QOL 5D for 30 days after the 7th day of clinical stability assessment.
Time Frame
30 days
Title
Evaluation of thirst sensation.
Description
Evaluation of thirst score on the Thirst Scale, daily for seven days.
Time Frame
Seven days
Title
Re-hospitalizations.
Description
Medical records assessed for 30 days after the 7th day of clinical stability assessment.
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luis B Silva-Neto, MD, ScD
Organizational Affiliation
Post Graduated Program of Federal University Program
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
23689381
Citation
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.
Results Reference
derived
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Fluid and Salt Restriction in Decompensated Heart Failure Patients
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