ClinicalTrials.Veeva

Menu

Daily Sodium Intake in Anuric Hemodialysis Patients and Interdialytic Weight Gain

Clalit Health Services logo

Clalit Health Services

Status

Unknown

Conditions

End Stage Kidney Disease

Treatments

Other: Dietary consultation

Study type

Interventional

Funder types

Other

Identifiers

NCT02792530
0654-15-RMC

Details and patient eligibility

About

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.

Full 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

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

arm 1
Other group
Description:
Unuric hemodialytic patients who accumulate above 2.5 (4%) in intradialytic intervals before the nutritional intervention.
Treatment:
Other: Dietary consultation

Trial contacts and locations

0

Loading...

Central trial contact

Merav Jacobson Naftali; Benaya Rozen Zvi,., Ph.D

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems