Dietary and Dialysate Sodium Reduction on Body Fluid Volume and Inflammatory State in Hemodialysis Patients
October 24, 2011 updated by: Lidiane Silva RodriguesTelini, UPECLIN HC FM Botucatu Unesp
Effects of Dietary and Dialysate Sodium Reduction on Body Fluid Volume and Inflammatory State in Hemodialysis Patients. A Prospective Randomized Controlled Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
59
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A
Composed by 21 patients treated with reduction of 2 grams of sodium reduction in their habitual diet.
|
Restriction of 2 grams on daily sodium diet intake.
Other Names:
|
|
Experimental: Group B
Composed by 20 patients treated by reduction of dialysate concentration from 138 to 135 mEq/L
|
Reduction of dialysate sodium concentration from 138 to 135 mEq/L
Other Names:
|
|
No Intervention: Group C
Composed by 18 patients followed without changes in dialysate sodium concentration or diet sodium amount.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
C-reactive protein
Time Frame: up to 16 weeks
|
The outcome will be evaluates each eight weeks
|
up to 16 weeks
|
|
interleukin-6
Time Frame: up to 16 weeks
|
The outcome will be evaluates each eight weeks
|
up to 16 weeks
|
|
alpha tumor necrosis serum concetrations
Time Frame: up to 16 weeks
|
The outcome will be evaluates each eight weeks
|
up to 16 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lidiane R. Telini, MSC, UPECLIN HC FM Botucatu Unesp
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2007
Primary Completion (Actual)
February 1, 2009
Study Completion (Actual)
February 1, 2009
Study Registration Dates
First Submitted
June 14, 2011
First Submitted That Met QC Criteria
October 24, 2011
First Posted (Estimate)
October 25, 2011
Study Record Updates
Last Update Posted (Estimate)
October 25, 2011
Last Update Submitted That Met QC Criteria
October 24, 2011
Last Verified
October 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- upeclin/HC/FMB-Unesp-55
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