We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Intensified Sodium Management in Hemodialysis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01015313
Recruitment Status : Withdrawn
First Posted : November 18, 2009
Last Update Posted : October 1, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Renal Failure Chronic Requiring Hemodialysis Other: intensive sodium management

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : November 2009
Primary Completion Date : February 2015
Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. feasibility of intensive sodium management [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. hospitalization [ Time Frame: 12 months ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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)
First Posted: November 18, 2009    Key Record Dates
Last Update Posted: October 1, 2015
Last Verified: September 2015

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