Effects of Intensified Sodium Management in Hemodialysis Patients

Not Applicable

Withdrawn

• Conditions: Renal Failure Chronic Requiring Hemodialysis
• Interventions: Other: intensive sodium management

• Registration Number: NCT01015313
• Lead Sponsor: Renal Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-17
• Study First Submitted QC: 2009-11-17
• Study First Posted: 2009-11-18
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-30
• Last Update Posted: 2015-10-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intensive sodium management	intensive sodium management	-

Primary Outcome Measures

Name	Time	Method
feasibility of intensive sodium management	12 months

Secondary Outcome Measures

Name	Time	Method
hospitalization	12 months

Trial Locations

Locations (3)

Irving Place Dialysis Center; 🇺🇸 New York, New York, United States

Yorkville Dialysis Center; 🇺🇸 New York, New York, United States

Upper Manhattan Dilaysis Center; 🇺🇸 New York, New York, United States