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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02792530
• Other study ID #: 0654-15-RMC
• Status: Not yet recruiting
• Phase: N/A
• First received: April 12, 2016
• Last updated: June 9, 2016
• Start date: August 2016

Study information

• Verified date: April 2016
• Source: Rabin Medical Center
• Contact: Benaya Rozen Zvi,., Ph.D
• Phone: 972-50-8773766
• Email: bnaiar[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 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

Intervention

Other:
• Dietary consultation
Dietary consultation for sodium restriction to decrease dietary intake to 2 grams/day less than the patients consume currently

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in intradialytic weight gain (IDWG)	Reduction in the weight gain at 2 subsequent hemodialysis in KG/	between baseline and 6 weeks	No
Secondary	dietary sodium intake.	as measured by food recall assesment	at baseline and 6 weeks	No
Secondary	Change in CRP values		between baseline and 6 weeks	No
Secondary	Changes in subjective global assesment (SGA)	SGA is a nutritional assesment measure	between baseline and 6 weeks	No
Secondary	change in predialysis blood pressure		between baseline and 6 weeks	No
Secondary	Changes in quality of life	assessed by SF 36	between baseline and 6 weeks	No
Secondary	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	Yes