End Stage Kidney Disease
Conditions
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
Interventions
OTHERDietary consultation
Dietary consultation for sodium restriction to decrease dietary intake to 2 grams/day less than the patients consume currently
Sponsors
Rabin Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in intradialytic weight gain (IDWG) | between baseline and 6 weeks | Reduction in the weight gain at 2 subsequent hemodialysis in KG/ |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in CRP values | between baseline and 6 weeks | — |
| Changes in subjective global assesment (SGA) | between baseline and 6 weeks | SGA is a nutritional assesment measure |
| dietary sodium intake. | at baseline and 6 weeks | as measured by food recall assesment |
| Changes in quality of life | between baseline and 6 weeks | assessed by SF 36 |
| number of hypotensive episode during dialysis | at baseline and 6 weeks | define as drop of more than 20 mm hg systolic blood pressure from baseline |
| change in predialysis blood pressure | between baseline and 6 weeks | — |
Contacts
Primary ContactBenaya Rozen Zvi,., Ph.D
Backup ContactMerav Jacobson Naftali
Outcome results
None listed