Effects of Intensified Sodium Management in Hemodialysis Patients

Withdrawn before enrolling · Not applicable

Conditions studied: Renal Failure Chronic Requiring Hemodialysis

In brief

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.

Key facts

Study ID

NCT01015313

Run by

Renal Research Institute

People needed

0

Starts

2009-11-01

Expected to finish

2015-02-01

Last updated by the study team

2015-10-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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