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Daily Sodium Intake in Anuric Hemodialysis Patients and Interdialytic Weight Gain

Primary Purpose

End Stage Kidney Disease

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dietary consultation
Sponsored by
Rabin Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Kidney Disease

Eligibility Criteria

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

Inclusion Criteria:

  1. Adults >18 years providing signed informed consent.
  2. Any patient more than 3 months in hemodialysis who reach his assigned dry weight.
  3. Intradialytic weight gain of more than 2.5 liters or 4% of dry body weight in two mid-week sessions.
  4. residual renal function of less than 200 ml per 24 hr.
  5. expected to stay on hemodialysis for at least 6 month.

Exclusion Criteria:

  1. Malnutrition as assessed by SGA: score C.
  2. Dementia
  3. Active malignancy
  4. Active infection

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    arm 1

    Arm Description

    Unuric hemodialytic patients who accumulate above 2.5 (4%) in intradialytic intervals before the nutritional intervention.

    Outcomes

    Primary Outcome Measures

    Reduction in intradialytic weight gain (IDWG)
    Reduction in the weight gain at 2 subsequent hemodialysis in KG/

    Secondary Outcome Measures

    dietary sodium intake.
    as measured by food recall assesment
    Change in CRP values
    Changes in subjective global assesment (SGA)
    SGA is a nutritional assesment measure
    change in predialysis blood pressure
    Changes in quality of life
    assessed by SF 36
    number of hypotensive episode during dialysis
    define as drop of more than 20 mm hg systolic blood pressure from baseline

    Full Information

    First Posted
    April 12, 2016
    Last Updated
    June 9, 2016
    Sponsor
    Rabin Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02792530
    Brief Title
    Daily Sodium Intake in Anuric Hemodialysis Patients and Interdialytic Weight Gain
    Official Title
    Daily Sodium Intake in Anuric Hemodialysis Patients and Interdialytic Weight Gain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2016 (undefined)
    Primary Completion Date
    May 2017 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Rabin Medical Center

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study will evaluate the efficiency of dietary intervention on intradialytic weight gain. Uniric hemodialysis patients without serious dietary complications, who accumulate above 2.5 kg (or above 4%) of their dry weight, will undergo a series of dietary consultations for sodium restriction. One month after the intervention, their intradialytic weight accumulation will be measured.
    Detailed Description
    Inter Dialytic Weight Gain (IDWG) ascribed to fluid retention is one of the major clinical problem that patients in hemodialysis need to cope with between 2 subsequent hemodialysis especially in patients with no residual renal function. Fluid retention is associated with morbid conditions such as lower-extremity edema, ascites, pulmonary vascular congestion or edema, hypertension, and worsening heart failure. Gain weight above 2 kg between 2 subsequent hemodialysis found to be in higher risk of all-cause mortality and cardiovascular death .Lowering daily sodium intake found to mitigate fluid retention ,however there are only a few researches that check it. 2IDWG also associated with poorer quality of life. Dietary sodium restriction recommendation since the beginning of hemodialysis are based on association of this restriction with balance of hypertension and fluid retention. Sodium intake recommended for patients in hemodialysis is limited to 2 grams a day. Nevertheless, there are only a few studies that examine the efficiency of this restriction because of the complexity of measurement of sodium intake. One recently published study which used a 24-h recall to measure sodium intake, found a direct correlation between IDGW and mortality form any reason. In spite of this complexity, IDWG has been found to be in a direct relation with patients' nutrition status. One of sodium-related issues is malnutrition. Malnutrition in dialysis is a risk factor for patients' morbidity and mortality. Higher sodium intake is associated with higher calorie and protein intake, while adherence to restriction of sodium intake is poor in hemodialysis. This is a reason for high importance to study effects of sodium restriction in people with more than 2.5 kg (or 4% of dry body weight) IDWG while following up their nutritional status

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    End Stage Kidney Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    arm 1
    Arm Type
    Other
    Arm Description
    Unuric hemodialytic patients who accumulate above 2.5 (4%) in intradialytic intervals before the nutritional intervention.
    Intervention Type
    Other
    Intervention Name(s)
    Dietary consultation
    Intervention Description
    Dietary consultation for sodium restriction to decrease dietary intake to 2 grams/day less than the patients consume currently
    Primary Outcome Measure Information:
    Title
    Reduction in intradialytic weight gain (IDWG)
    Description
    Reduction in the weight gain at 2 subsequent hemodialysis in KG/
    Time Frame
    between baseline and 6 weeks
    Secondary Outcome Measure Information:
    Title
    dietary sodium intake.
    Description
    as measured by food recall assesment
    Time Frame
    at baseline and 6 weeks
    Title
    Change in CRP values
    Time Frame
    between baseline and 6 weeks
    Title
    Changes in subjective global assesment (SGA)
    Description
    SGA is a nutritional assesment measure
    Time Frame
    between baseline and 6 weeks
    Title
    change in predialysis blood pressure
    Time Frame
    between baseline and 6 weeks
    Title
    Changes in quality of life
    Description
    assessed by SF 36
    Time Frame
    between baseline and 6 weeks
    Title
    number of hypotensive episode during dialysis
    Description
    define as drop of more than 20 mm hg systolic blood pressure from baseline
    Time Frame
    at baseline and 6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adults >18 years providing signed informed consent. Any patient more than 3 months in hemodialysis who reach his assigned dry weight. Intradialytic weight gain of more than 2.5 liters or 4% of dry body weight in two mid-week sessions. residual renal function of less than 200 ml per 24 hr. expected to stay on hemodialysis for at least 6 month. Exclusion Criteria: Malnutrition as assessed by SGA: score C. Dementia Active malignancy Active infection
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Benaya Rozen Zvi,., Ph.D
    Phone
    972-50-8773766
    Email
    bnaiar@clalit.org.il
    First Name & Middle Initial & Last Name or Official Title & Degree
    Merav Jacobson Naftali
    Phone
    972-50-7778369
    Email
    merav.j.n@gmail.com

    12. IPD Sharing Statement

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    Daily Sodium Intake in Anuric Hemodialysis Patients and Interdialytic Weight Gain

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