Daily Sodium Intake in Anuric Hemodialysis Patients and Interdialytic Weight Gain

End Stage Kidney Disease Clinical Trial

Official title: Daily Sodium Intake in Anuric Hemodialysis Patients and Interdialytic Weight Gain

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• End Stage Kidney Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic
• Weight Gain

• NCT number: NCT02792530
• Study type: Interventional
• Source: Rabin Medical Center
• Contact: Benaya Rozen Zvi,., Ph.D
• Phone: 972-50-8773766
• Email: bnaiar@clalit.org.il
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2016