Effects of Intensified Sodium Management in Hemodialysis... | NCT01015313

Studies
Effects of Intensified Sodium Management in Hemodialysis Patients

NCT01015313

Sponsor

Renal Research Institute

Status

Withdrawn

Last Update Posted

Oct 1, 2015Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Renal Failure Chronic Requiring Hemodialysis

Interventions

intensive sodium management

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2009

Primary Completion Date

Feb 2015Actual

Completion Date

Feb 2015Actual

First Submitted Date

Nov 17, 2009

First Submission Date that Met QC Criteria

Nov 17, 2009

First Posted Date

Nov 18, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 30, 2015

Last Update Posted Date

Oct 1, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
intensive sodium management	Experimental		Other: intensive sodium management
standard care	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
intensive sodium management	Other	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

Measure	Description	Time Frame
feasibility of intensive sodium management		12 months

Measure	Description	Time Frame
hospitalization		12 months

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peter Kotanko, MD	Renal Research Institute	Principal Investigator
Nathan W Levin, MD	Renal Research Institute	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Irving Place Dialysis Center		New York	New York	10003	United States
Upper Manhattan Dilaysis Center

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34164803	Derived	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.

ID	Term
D006973	Hypertension
D004487	Edema

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms