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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01458808
First Posted: October 25, 2011
Last Update Posted: October 25, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Lidiane Silva RodriguesTelini, UPECLIN HC FM Botucatu Unesp
  Purpose

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.


Condition Intervention Phase
Chronic Kidney Diseases Stage 5 Other: Dietary sodium restriction Other: Dialysate sodium concentration reduction Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Dietary and Dialysate Sodium Reduction on Body Fluid Volume and Inflammatory State in Hemodialysis Patients. A Prospective Randomized Controlled Study

Resource links provided by NLM:


Further study details as provided by Lidiane Silva RodriguesTelini, UPECLIN HC FM Botucatu Unesp:

Primary Outcome Measures:
  • C-reactive protein [ Time Frame: up to 16 weeks ]
    The outcome will be evaluates each eight weeks

  • interleukin-6 [ Time Frame: up to 16 weeks ]
    The outcome will be evaluates each eight weeks

  • alpha tumor necrosis serum concetrations [ Time Frame: up to 16 weeks ]
    The outcome will be evaluates each eight weeks


Enrollment: 59
Study Start Date: April 2007
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Composed by 21 patients treated with reduction of 2 grams of sodium reduction in their habitual diet.
Other: Dietary sodium restriction
Restriction of 2 grams on daily sodium diet intake.
Other Name: Dietary prescription
Experimental: Group B
Composed by 20 patients treated by reduction of dialysate concentration from 138 to 135 mEq/L
Other: Dialysate sodium concentration reduction
Reduction of dialysate sodium concentration from 138 to 135 mEq/L
Other Name: Dialysis prescription
No Intervention: Group C
Composed by 18 patients followed without changes in dialysate sodium concentration or diet sodium amount.

Detailed Description:
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.
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01458808


Sponsors and Collaborators
UPECLIN HC FM Botucatu Unesp
Investigators
Principal Investigator: Lidiane R. Telini, MSC UPECLIN HC FM Botucatu Unesp
  More Information

Responsible Party: Lidiane Silva RodriguesTelini, MSC, UPECLIN HC FM Botucatu Unesp
ClinicalTrials.gov Identifier: NCT01458808     History of Changes
Other Study ID Numbers: upeclin/HC/FMB-Unesp-55
First Submitted: June 14, 2011
First Posted: October 25, 2011
Last Update Posted: October 25, 2011
Last Verified: October 2011

Keywords provided by Lidiane Silva RodriguesTelini, UPECLIN HC FM Botucatu Unesp:
salt
inflammation
hypervolemia
diet

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency
Dialysis Solutions
Pharmaceutical Solutions