Effects of Dietary and Dialysate Sodium Reduction on Body Fluid Volume and Inflammatory State in Hemodialysis Patients. A Prospective Randomized Controlled Study

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

Sponsors

Lead sponsor: UPECLIN HC FM Botucatu Unesp

Source UPECLIN HC FM Botucatu Unesp
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.

Overall Status Completed
Start Date April 2007
Completion Date February 2009
Primary Completion Date February 2009
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
C-reactive protein up to 16 weeks
interleukin-6 up to 16 weeks
alpha tumor necrosis serum concetrations up to 16 weeks
Enrollment 59
Condition
Intervention

Intervention type: Other

Intervention name: Dietary sodium restriction

Description: Restriction of 2 grams on daily sodium diet intake.

Arm group label: Group A

Other name: Dietary prescription

Intervention type: Other

Intervention name: Dialysate sodium concentration reduction

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

Arm group label: Group B

Other name: Dialysis prescription

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Lidiane R. Telini, MSC Principal Investigator UPECLIN HC FM Botucatu Unesp
Verification Date

October 2011

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: UPECLIN HC FM Botucatu Unesp

Investigator full name: Lidiane Silva RodriguesTelini

Investigator title: MSC

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Arm group label: Group A

Arm group type: Experimental

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

Arm group label: Group B

Arm group type: Experimental

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

Arm group label: Group C

Arm group type: No Intervention

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

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov