Effects of Intensified Sodium Management in Hemodialysis Patients

Renal Failure Chronic Requiring Hemodialysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01015313
• Other study ID #: 208-12 (formerly 173-09)
• Status: Withdrawn
• Phase: N/A
• First received: November 17, 2009
• Last updated: September 30, 2015
• Start date: November 2009
• Est. completion date: February 2015

Study information

• Verified date: September 2015
• Source: Renal Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Renal Failure Chronic Requiring Hemodialysis

Intervention

Other:
• intensive sodium management
dietary sodium restriction avoiding positive sodium balance during dialysis by: aligning dialysate sodium with plasma sodium, avoiding sodium profiling, and avoiding saline solutions to treat intradialytic symptoms

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Renal Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	feasibility of intensive sodium management		12 months	No
Secondary	hospitalization		12 months	No