NCT01015313

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 18, 2009

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

October 1, 2015

Status Verified

September 1, 2015

Enrollment Period

5.3 years

First QC Date

November 17, 2009

Last Update Submit

September 30, 2015

Conditions

Renal Failure Chronic Requiring Hemodialysis

Keywords

sodium, hypertension, volume overload

Outcome Measures

Primary Outcomes (1)

  • feasibility of intensive sodium management

    12 months

Secondary Outcomes (1)

  • hospitalization

    12 months

Study Arms (2)

intensive sodium management

EXPERIMENTAL
Other: intensive sodium management

standard care

NO INTERVENTION

Interventions

intensive sodium managementOTHER

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

intensive sodium management

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Irving Place Dialysis Center

New York, New York, 10003, United States

Location

Upper Manhattan Dilaysis Center

New York, New York, 10025, United States

Location

Yorkville Dialysis Center

New York, New York, 10128, United States

Location

Related Publications (1)

  • 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.

    PMID: 34164803DERIVED

MeSH Terms

Conditions

HypertensionEdema

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Peter Kotanko, MD

    Renal Research Institute

    PRINCIPAL INVESTIGATOR

  • Nathan W Levin, MD

    Renal Research Institute

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2009

First Posted

November 18, 2009

Study Start

November 1, 2009

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

October 1, 2015

Record last verified: 2015-09

Locations

US(3)