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

UPECLIN HC FM Botucatu Unesp

Status and phase: Completed; Phase 4

Conditions: Chronic Kidney Diseases Stage 5

Treatments: Other: Dialysate sodium concentration reduction; Other: Dietary sodium restriction

Study type: Interventional

Funder types: Other

Identifiers

NCT01458808

upeclin/HC/FMB-Unesp-55

Details and patient eligibility

About

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.

Full 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.

Enrollment: 59 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

59 participants in 3 patient groups

Group A

Experimental group

Description:

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

Treatment:

Other: Dietary sodium restriction

Group B

Experimental group

Description:

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

Treatment:

Other: Dialysate sodium concentration reduction

Group C

No Intervention group

Description:

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