Effects of Intensified Sodium Management in Hemodialysis Patients

Renal Research Institute

Status

Withdrawn

Conditions

Renal Failure Chronic Requiring Hemodialysis

Treatments

Other: intensive sodium management

Study type

Interventional

Funder types

Other

Identifiers

NCT01015313

208-12 (formerly 173-09)

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No 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