Effects of Intensified Sodium Management in Hemodialysis Patients

A Multi-center, Randomized, Controlled and Prospective Pilot Study on the Effects of Intensified Sodium Management on Hospitalization in Chronic Hemodialysis Patients.

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01015313

Enrollment

Registered

2009-11-18

Start date

2009-11-30

Completion date

2015-02-28

Last updated

2015-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Failure Chronic Requiring Hemodialysis

Keywords

sodium, hypertension, volume overload

Brief summary

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.

Interventions

OTHERintensive sodium management

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
feasibility of intensive sodium management	12 months

Secondary

Measure	Time frame
hospitalization	12 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026