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Effects of Intensified Sodium Management in Hemodialysis Patients

This study is currently recruiting participants.
Verified March 2013 by Renal Research Institute
Sponsor:
Information provided by (Responsible Party):
Renal Research Institute
ClinicalTrials.gov Identifier:
NCT01015313
First received: November 17, 2009
Last updated: March 26, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention
Renal Failure Chronic Requiring Hemodialysis
 Other: intensive sodium management

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized, Controlled and Prospective Pilot Study on the Effects of Intensified Sodium Management on Hospitalization in Chronic Hemodialysis Patients.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Renal Research Institute:

Primary Outcome Measures:
  • feasibility of intensive sodium management [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • hospitalization [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: November 2009
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: intensive sodium management Other: intensive sodium management
  1. dietary sodium restriction
  2. avoiding positive sodium balance during dialysis by: aligning dialysate sodium with plasma sodium, avoiding sodium profiling, and avoiding saline solutions to treat intradialytic symptoms
No Intervention: standard care

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01015313

Contacts
Contact: Rebecca Apruzzese 646-672-4058 rapruzzese@rriny.com

Locations
United States, New York
Yorkville Dialysis Center Recruiting
New York, New York, United States, 10128
Upper Manhattan Dilaysis Center Not yet recruiting
New York, New York, United States, 10025
Irving Place Dialysis Center Not yet recruiting
New York, New York, United States, 10003
Sponsors and Collaborators
Renal Research Institute
Investigators
Principal Investigator: Peter Kotanko, MD Renal Research Institute
Study Director: Nathan W Levin, MD Renal Research Institute
  More Information

No publications provided

Responsible Party: Renal Research Institute
ClinicalTrials.gov Identifier: NCT01015313     History of Changes
Other Study ID Numbers: 173-09
Study First Received: November 17, 2009
Last Updated: March 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Renal Research Institute:
sodium, hypertension, volume overload

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 22, 2013