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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
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Salt restriction, Fluid restriction, Congestion, Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    November 9, 2009
    Last Updated
    December 31, 2013
    Sponsor
    Hospital de Clinicas de Porto Alegre
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    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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