Dietary and Dialysate Sodium Reduction on Body Fluid Volume and Inflammatory State in Hemodialysis Patients

Study Overview
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Brief Summary
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Objective: To evaluate the influence of dietary sodium reduction on body fluid volume and inflammatory state in hemodialysis (HD) patients. Design: Prospective controlled randomized study. Setting: Dialysis Unit of Botucatu Medical School Hospital, Sao Paulo State University, Brazil. Patients: Adult patients on HD for at least 30 days and C-reactive protein (CRP) ≥ 0.7 mg/dl were randomly allocated into two groups: Group A: 21 patients treated with a 2g sodium restriction in their habitual diet, and Group B: 18 controls. Inflammatory, biochemical, hematological and nutritional markers, as well as dialysis dosage were assessed at baseline and after 8 and 16 weeks.

Detailed Description
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The prognosis of chronic kidney diseases (CKD) patients is strongly compromised by cardiovascular (CV) complications. Inflammation is established as a major risk factor for CV complications in these patients, occurring in approximately one third of them. Recently, growing evidences have suggested the body water volume expansion is a cause of inflammation in CKD. In a previous study Rodrigues Telini showed that dietary sodium restriction reduced the inflammatory markers levels in hemodialysis (HD) patients. Similar results were observed in patients treated by reduction of HD dialysate sodium concentration. However in both studies no significant reduction in body volume markers was observed. These results could be due to small number of patients or low sensibility of volume markers; on the other hand they could suggest a direct role of sodium as an inflammatory inducer independently of volume. With a larger number of patients and using a more sensitive volume marker as the B-type natriuretic peptide (BNP), this study intends to confirm the hypothesis that sodium mobilization can reduce the body water volume and attenuate the inflammatory in HD patients. A hundred thirty-five patients will be enrolled and divided in three groups with 35 patients: A, treated by reduction of 2 grams in daily sodium intake; B, exposed to reduction of sodium dialysate from 138 to 135 mEq/L and C, control group. The patients will be followed up by 16 weeks and inflammatory markers (CRP, interleukin-6, and tumor necrosis factor) as well as volume markers (Watson formula, electrical bioimpedance measurements and BNP concentration) will be determine each 8 weeks.

Official Title
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Effects of Dietary and Dialysate Sodium Reduction on Body Fluid Volume and Inflammatory State in Hemodialysis Patients. A Prospective Randomized Controlled Study

Conditions
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Chronic Kidney Diseases Stage 5

Intervention / Treatment
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* Other: Dietary sodium restriction
* Other: Dialysate sodium concentration reduction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: included patients aged ≥ 18 years who had been on hemodialysis for at least 90 days, and were diagnosed with inflammation. Inflammation was defined as C Reactive Protein ≥ 0.7 mg/dL Exclusion Criteria: acute inflammatory processes confirmed by clinical criteria and/or complementary tests acute inflammatory diseases tuberculosis use of antibiotics within the past two months chronic inflammatory diseases neoplasias chronic obstructive pulmonary disease use of central venous catheter and positive HIV serology

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Composed by 21 patients treated with reduction of 2 grams of sodium reduction in their habitual diet. | Other: Dietary sodium restriction<br>* Restriction of 2 grams on daily sodium diet intake.<br>* Other names: Dietary prescription;|
| Experimental: Group B<br>Composed by 20 patients treated by reduction of dialysate concentration from 138 to 135 mEq/L | Other: Dialysate sodium concentration reduction<br>* Reduction of dialysate sodium concentration from 138 to 135 mEq/L<br>* Other names: Dialysis prescription;|
| No Intervention: Group C<br>Composed by 18 patients followed without changes in dialysate sodium concentration or diet sodium amount. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C-reactive protein | The outcome will be evaluates each eight weeks | up to 16 weeks | 
| interleukin-6 | The outcome will be evaluates each eight weeks | up to 16 weeks | 
| alpha tumor necrosis serum concetrations | The outcome will be evaluates each eight weeks | up to 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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salt, inflammation, hypervolemia, diet