- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01015313
Effects of Intensified Sodium Management in Hemodialysis Patients
September 30, 2015 updated by: Renal Research Institute
A Multi-center, Randomized, Controlled and Prospective Pilot Study on the Effects of Intensified Sodium Management on Hospitalization in Chronic Hemodialysis Patients.
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10128
- Yorkville Dialysis Center
-
New York, New York, United States, 10003
- Irving Place Dialysis Center
-
New York, New York, United States, 10025
- Upper Manhattan Dilaysis Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: standard care
|
|
EXPERIMENTAL: intensive sodium management
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
feasibility of intensive sodium management
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
hospitalization
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Nathan W Levin, MD, Renal Research Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2009
Primary Completion (ACTUAL)
February 1, 2015
Study Completion (ACTUAL)
February 1, 2015
Study Registration Dates
First Submitted
November 17, 2009
First Submitted That Met QC Criteria
November 17, 2009
First Posted (ESTIMATE)
November 18, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
October 1, 2015
Last Update Submitted That Met QC Criteria
September 30, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 208-12 (formerly 173-09)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Renal Failure Chronic Requiring Hemodialysis
-
Rockwell Medical Technologies, Inc.CompletedRenal Failure Chronic Requiring HemodialysisUnited States, Puerto Rico
-
Rockwell Medical Technologies, Inc.CompletedRenal Failure Chronic Requiring HemodialysisUnited States, Canada
-
Baxter Healthcare CorporationUniversity of Louisville; Gambro Renal Products, Inc.CompletedRenal Failure Chronic Requiring HemodialysisUnited States
-
Kantonsspital AarauFresenius Medical Care Deutschland GmbHCompletedRenal Failure Chronic Requiring HemodialysisSwitzerland
-
Sin-Lau HospitalUnknownRenal Failure Chronic Requiring HemodialysisTaiwan
-
Baxter Healthcare CorporationGambro Dialysatoren GmbHCompletedRenal Failure Chronic Requiring HemodialysisAustria
-
University Hospital, LimogesTerminatedRenal Failure Chronic Requiring HemodialysisFrance
-
University of PennsylvaniaTeleflex; Arrow InternationalCompletedRenal Failure Chronic Requiring Hemodialysis | Chronic Renal InsufficiencyUnited States
-
Catherine SullivanCompletedRenal Failure Chronic Requiring Hemodialysis | Kidney TransplantUnited States
-
PfizerCompletedChronic Renal Failure Requiring HemodialysisUnited States, Puerto Rico
Clinical Trials on intensive sodium management
-
Wake Forest University Health SciencesCompletedHypertension SecondaryUnited States
-
Wake Forest University Health SciencesNot yet recruiting
-
Assistance Publique - Hôpitaux de ParisInstitut National de la Santé Et de la Recherche Médicale, FranceCompletedActive Second StageFrance
-
Hospital Clinic of BarcelonaInstitut d'Investigacions Biomèdiques August Pi i Sunyer; Hospital Sant Joan...Completed
-
Assistance Publique - Hôpitaux de ParisCompleted
-
Washington University School of MedicineBarnes-Jewish HospitalTerminated
-
Thomas G. Brott, M.D.National Institute of Neurological Disorders and Stroke (NINDS)RecruitingCarotid StenosisUnited States, Canada, Israel, Spain, Australia
-
New York City Health and Hospitals CorporationNew York State Department of HealthCompletedHigh-risk, High-cost Medicaid Services UsersUnited States
-
Medtronic - MITGCompletedCardiovascular Disease | Type 2 DiabetesUnited States, Taiwan