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Effects of Intensified Sodium Management in Hemodialysis Patients

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Renal Research Institute
ClinicalTrials.gov Identifier:
NCT01015313
First received: November 17, 2009
Last updated: September 30, 2015
Last verified: September 2015
  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:


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 ]

Enrollment: 0
Study Start Date: November 2009
Study Completion Date: February 2015
Primary Completion Date: February 2015 (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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01015313

Locations
United States, New York
Irving Place Dialysis Center
New York, New York, United States, 10003
Upper Manhattan Dilaysis Center
New York, New York, United States, 10025
Yorkville Dialysis Center
New York, New York, United States, 10128
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

Responsible Party: Renal Research Institute
ClinicalTrials.gov Identifier: NCT01015313     History of Changes
Other Study ID Numbers: 208-12 (formerly 173-09) 
Study First Received: November 17, 2009
Last Updated: September 30, 2015
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 23, 2016