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
About this trial
This is an interventional treatment trial for End Stage Kidney Disease
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
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
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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