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

NCT ID: NCT01458808

Last Updated: 2011-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2009-02-28

Brief Summary

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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

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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.

Conditions

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Chronic Kidney Diseases Stage 5

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

Composed by 21 patients treated with reduction of 2 grams of sodium reduction in their habitual diet.

Group Type EXPERIMENTAL

Dietary sodium restriction

Intervention Type OTHER

Restriction of 2 grams on daily sodium diet intake.

Group B

Composed by 20 patients treated by reduction of dialysate concentration from 138 to 135 mEq/L

Group Type EXPERIMENTAL

Dialysate sodium concentration reduction

Intervention Type OTHER

Reduction of dialysate sodium concentration from 138 to 135 mEq/L

Group C

Composed by 18 patients followed without changes in dialysate sodium concentration or diet sodium amount.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Dietary sodium restriction

Restriction of 2 grams on daily sodium diet intake.

Intervention Type OTHER

Dialysate sodium concentration reduction

Reduction of dialysate sodium concentration from 138 to 135 mEq/L

Intervention Type OTHER

Other Intervention Names

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Dietary prescription Dialysis prescription

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UPECLIN HC FM Botucatu Unesp

OTHER

Sponsor Role lead

Responsible Party

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Lidiane Silva RodriguesTelini

MSC

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lidiane R. Telini, MSC

Role: PRINCIPAL_INVESTIGATOR

UPECLIN HC FM Botucatu Unesp

References

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Marshall MR, Wang MY, Vandal AC, Dunlop JL. Low dialysate sodium levels for chronic haemodialysis. Cochrane Database Syst Rev. 2024 Nov 5;11(11):CD011204. doi: 10.1002/14651858.CD011204.pub3.

Reference Type DERIVED
PMID: 39498822 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34164803 (View on PubMed)

Other Identifiers

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upeclin/HC/FMB-Unesp-55

Identifier Type: -

Identifier Source: org_study_id