Dietary and Dialysate Sodium Reduction on Body Fluid Volume and Inflammatory State in Hemodialysis Patients
Primary Purpose
Chronic Kidney Diseases Stage 5
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Dietary sodium restriction
Dialysate sodium concentration reduction
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Diseases Stage 5 focused on measuring salt, inflammation, hypervolemia, diet
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Group A
Group B
Group C
Arm Description
Composed by 21 patients treated with reduction of 2 grams of sodium reduction in their habitual diet.
Composed by 20 patients treated by reduction of dialysate concentration from 138 to 135 mEq/L
Composed by 18 patients followed without changes in dialysate sodium concentration or diet sodium amount.
Outcomes
Primary Outcome Measures
C-reactive protein
The outcome will be evaluates each eight weeks
interleukin-6
The outcome will be evaluates each eight weeks
alpha tumor necrosis serum concetrations
The outcome will be evaluates each eight weeks
Secondary Outcome Measures
Full Information
NCT ID
NCT01458808
First Posted
June 14, 2011
Last Updated
October 24, 2011
Sponsor
UPECLIN HC FM Botucatu Unesp
1. Study Identification
Unique Protocol Identification Number
NCT01458808
Brief Title
Dietary and Dialysate Sodium Reduction on Body Fluid Volume and Inflammatory State in Hemodialysis Patients
Official Title
Effects of Dietary and Dialysate Sodium Reduction on Body Fluid Volume and Inflammatory State in Hemodialysis Patients. A Prospective Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UPECLIN HC FM Botucatu Unesp
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases Stage 5
Keywords
salt, inflammation, hypervolemia, diet
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
Composed by 21 patients treated with reduction of 2 grams of sodium reduction in their habitual diet.
Arm Title
Group B
Arm Type
Experimental
Arm Description
Composed by 20 patients treated by reduction of dialysate concentration from 138 to 135 mEq/L
Arm Title
Group C
Arm Type
No Intervention
Arm Description
Composed by 18 patients followed without changes in dialysate sodium concentration or diet sodium amount.
Intervention Type
Other
Intervention Name(s)
Dietary sodium restriction
Other Intervention Name(s)
Dietary prescription
Intervention Description
Restriction of 2 grams on daily sodium diet intake.
Intervention Type
Other
Intervention Name(s)
Dialysate sodium concentration reduction
Other Intervention Name(s)
Dialysis prescription
Intervention Description
Reduction of dialysate sodium concentration from 138 to 135 mEq/L
Primary Outcome Measure Information:
Title
C-reactive protein
Description
The outcome will be evaluates each eight weeks
Time Frame
up to 16 weeks
Title
interleukin-6
Description
The outcome will be evaluates each eight weeks
Time Frame
up to 16 weeks
Title
alpha tumor necrosis serum concetrations
Description
The outcome will be evaluates each eight weeks
Time Frame
up to 16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lidiane R. Telini, MSC
Organizational Affiliation
UPECLIN HC FM Botucatu Unesp
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
34164803
Citation
McMahon EJ, Campbell KL, Bauer JD, Mudge DW, Kelly JT. Altered dietary salt intake for people with chronic kidney disease. Cochrane Database Syst Rev. 2021 Jun 24;6(6):CD010070. doi: 10.1002/14651858.CD010070.pub3.
Results Reference
derived
Learn more about this trial
Dietary and Dialysate Sodium Reduction on Body Fluid Volume and Inflammatory State in Hemodialysis Patients
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