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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

Phase 4
18 Years
Not Enrolling
Chronic Kidney Diseases Stage 5

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Trial Information

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

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.

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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

C-reactive protein

Outcome Description:

The outcome will be evaluates each eight weeks

Outcome Time Frame:

up to 16 weeks

Safety Issue:


Principal Investigator

Lidiane R. Telini, MSC

Investigator Role:

Principal Investigator

Investigator Affiliation:

UPECLIN HC FM Botucatu Unesp


Brazil: National Committee of Ethics in Research

Study ID:




Start Date:

April 2007

Completion Date:

February 2009

Related Keywords:

  • Chronic Kidney Diseases Stage 5
  • salt
  • inflammation
  • hypervolemia
  • diet
  • Kidney Diseases
  • Renal Insufficiency, Chronic
  • Kidney Failure, Chronic