Daily Sodium Intake in Anuric Hemodialysis Patients and Interdialytic Weight Gain

Sponsor

Rabin Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT02792530

Collaborator

(none)

Enrollment

Arm

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
End Stage Kidney Disease	Other: Dietary consultation	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Daily Sodium Intake in Anuric Hemodialysis Patients and Interdialytic Weight Gain

Study Start Date :

Aug 1, 2016

Anticipated Primary Completion Date :

May 1, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Reduction in intradialytic weight gain (IDWG) [between baseline and 6 weeks]
Reduction in the weight gain at 2 subsequent hemodialysis in KG/

Secondary Outcome Measures

dietary sodium intake. [at baseline and 6 weeks]
as measured by food recall assesment
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
change in predialysis blood pressure [between baseline and 6 weeks]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Rabin Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rabin Medical Center

ClinicalTrials.gov Identifier:

NCT02792530

Other Study ID Numbers:

0654-15-RMC

First Posted:

Jun 7, 2016

Last Update Posted:

Jun 10, 2016

Last Verified:

Apr 1, 2016

Additional relevant MeSH terms:

Kidney Diseases

Kidney Failure, Chronic

Weight Gain

Study Results

No Results Posted as of Jun 10, 2016