Daily Sodium Intake in Anuric Hemodialysis Patients and Interdialytic Weight Gain

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.

Study Overview

• Status: Unknown
• Conditions: End Stage Kidney Disease
• Intervention / Treatment: Other: Dietary consultation

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

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Benaya Rozen Zvi,., Ph.D; Phone Number: 972-50-8773766; Email: bnaiar@clalit.org.il
• Study Contact Backup: Name: Merav Jacobson Naftali; Phone Number: 972-50-7778369; Email: merav.j.n@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: arm 1; Unuric hemodialytic patients who accumulate above 2.5 (4%) in intradialytic intervals before the nutritional intervention.	Other: Dietary consultation; Dietary consultation for sodium restriction to decrease dietary intake to 2 grams/day less than the patients consume currently

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in intradialytic weight gain (IDWG)	Reduction in the weight gain at 2 subsequent hemodialysis in KG/	between baseline and 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
dietary sodium intake.	as measured by food recall assesment	at baseline and 6 weeks
Change in CRP values		between baseline and 6 weeks
Changes in subjective global assesment (SGA)	SGA is a nutritional assesment measure	between baseline and 6 weeks
change in predialysis blood pressure		between baseline and 6 weeks
Changes in quality of life	assessed by SF 36	between baseline and 6 weeks
number of hypotensive episode during dialysis	define as drop of more than 20 mm hg systolic blood pressure from baseline	at baseline and 6 weeks

Collaborators and Investigators

• Sponsor: Rabin Medical Center

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Anticipated): May 1, 2017

Study Registration Dates

• First Submitted: April 12, 2016
• First Submitted That Met QC Criteria: June 6, 2016
• First Posted (Estimate): June 7, 2016

Study Record Updates

• Last Update Posted (Estimate): June 10, 2016
• Last Update Submitted That Met QC Criteria: June 9, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Body Weight; Body Weight Changes; Renal Insufficiency, Chronic; Kidney Diseases; Kidney Failure, Chronic; Weight Gain
• Other Study ID Numbers: 0654-15-RMC