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

Chronic Kidney Diseases Stage 5 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01458808
• Other study ID #: upeclin/HC/FMB-Unesp-55
• Status: Completed
• Phase: Phase 4
• First received: June 14, 2011
• Last updated: October 24, 2011
• Start date: April 2007
• Est. completion date: February 2009

Study information

• Verified date: October 2011
• Source: UPECLIN HC FM Botucatu Unesp
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Diseases Stage 5
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Other:
• Dietary sodium restriction
Restriction of 2 grams on daily sodium diet intake.
• Dialysate sodium concentration reduction
Reduction of dialysate sodium concentration from 138 to 135 mEq/L

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UPECLIN HC FM Botucatu Unesp

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	C-reactive protein	The outcome will be evaluates each eight weeks	up to 16 weeks	Yes
Primary	interleukin-6	The outcome will be evaluates each eight weeks	up to 16 weeks	Yes
Primary	alpha tumor necrosis serum concetrations	The outcome will be evaluates each eight weeks	up to 16 weeks	Yes