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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
UPECLIN HC FM Botucatu Unesp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Diseases Stage 5 focused on measuring salt, inflammation, hypervolemia, diet

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    June 14, 2011
    Last Updated
    October 24, 2011
    Sponsor
    UPECLIN HC FM Botucatu Unesp
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    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

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

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