Effects of Intensified Sodium Management in Hemodialysis Patients

Renal Research Institute

Overview

The primary aim of this study is to investigate whether intensive sodium management by dietary sodium restriction and by preventing positive sodium balance during dialysis can be successfully applied in chronic hemodialysis patients. Secondary aims are to test if sodium restriction has positive effects on the frequency of hospital admissions, blood pressure, fluid overload, quality of life and residual renal function.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Renal Failure Chronic Requiring Hemodialysis

Interventions

intensive sodium managementOTHER

1. dietary sodium restriction 2. avoiding positive sodium balance during dialysis by: aligning dialysate sodium with plasma sodium, avoiding sodium profiling, and avoiding saline solutions to treat intradialytic symptoms

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Ambulatory, clinically stable maintenance hemodialysis patients on a thrice weekly HD regimen. * Willing and able to provide written, signed informed consent after the nature of the study has been explained. * Willing and able to comply with all study procedures. * Age ≥18 years. Exclusion Criteria: * Simultaneous participation in another clinical study except observational trials. * Any psychological condition which could interfere with the patient's ability to comply with the study protocol. * Pregnancy. * Amputation of a limb. * Pacemaker, implantable pump, artificial joint. * Expectation that native kidney function will recover. * Unable to verbally communicate in English or Spanish. * Scheduled for living donor kidney transplant, change to peritoneal dialysis, home HD or plans to relocate to another center within the next 14 months. * Life expectancy \< 15 months

Locations (3)

Irving Place Dialysis Center

New York, New York, United States

Upper Manhattan Dilaysis Center

New York, New York, United States

Yorkville Dialysis Center

New York, New York, United States

Outcomes

Primary Outcomes

feasibility of intensive sodium management

Time frame: 12 months

Secondary Outcomes

hospitalization

Time frame: 12 months

Data from ClinicalTrials.gov

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