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Effects of Intensified Sodium Management in Hemodialysis Patients

Primary Purpose

Renal Failure Chronic Requiring Hemodialysis

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
intensive sodium management
Sponsored by
Renal Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Failure Chronic Requiring Hemodialysis focused on measuring sodium, hypertension, volume overload

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Irving Place Dialysis Center
  • Upper Manhattan Dilaysis Center
  • Yorkville Dialysis Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

intensive sodium management

standard care

Arm Description

Outcomes

Primary Outcome Measures

feasibility of intensive sodium management

Secondary Outcome Measures

hospitalization

Full Information

First Posted
November 17, 2009
Last Updated
September 30, 2015
Sponsor
Renal Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01015313
Brief Title
Effects of Intensified Sodium Management in Hemodialysis Patients
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 Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Withdrawn
Study Start Date
November 2009 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Renal Research Institute

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Failure Chronic Requiring Hemodialysis
Keywords
sodium, hypertension, volume overload

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intensive sodium management
Arm Type
Experimental
Arm Title
standard care
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
intensive sodium management
Intervention Description
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
Primary Outcome Measure Information:
Title
feasibility of intensive sodium management
Time Frame
12 months
Secondary Outcome Measure Information:
Title
hospitalization
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Kotanko, MD
Organizational Affiliation
Renal Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nathan W Levin, MD
Organizational Affiliation
Renal Research Institute
Official's Role
Study Director
Facility Information:
Facility Name
Irving Place Dialysis Center
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Upper Manhattan Dilaysis Center
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
Facility Name
Yorkville Dialysis Center
City
New York
State/Province
New York
ZIP/Postal Code
10128
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34164803
Citation
McMahon EJ, Campbell KL, Bauer JD, Mudge DW, Kelly JT. Altered dietary salt intake for people with chronic kidney disease. Cochrane Database Syst Rev. 2021 Jun 24;6(6):CD010070. doi: 10.1002/14651858.CD010070.pub3.
Results Reference
derived

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Effects of Intensified Sodium Management in Hemodialysis Patients

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