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

Renal Research Institute3 sites in 1 countryNovember 2009

ConditionsRenal Failure Chronic Requiring Hemodialysis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Renal Failure Chronic Requiring Hemodialysis
Sponsor: Renal Research Institute
Locations: 3
Primary Endpoint: feasibility of intensive sodium management
Status: Withdrawn
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2009

End Date

February 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Renal Research Institute

Responsible Party

Sponsor

Eligibility Criteria

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