Effects of Simple Sodium Alignment on Clinical Outcomes

February 23, 2016 updated by: Renal Research Institute

Effects of Simple Sodium Alignment on Short-, Medium- and Long-term Clinical and Laboratory Outcome Measures

A difference between dialysate and serum sodium concentration leads to diffusive sodium transfer across the dialyzer membrane. The consequences of diffusive sodium flux into the patient can be chronic sodium overload leading to overhydration, hypertension, cardiovascular disease, and other problems. Diffusive sodium flux out of the patient can lead to intradialytic blood pressure instability. A simple strategy for alignment of dialysate and serum sodium concentrations was implemented starting in April/May 2010 in order to minimize the problems particularly associated with chronic sodium overload.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this database analysis is to assess the impact that this operational change has had in the short, medium and long term on key clinical and laboratory parameters in the patients, including blood pressure, body weight, interdialytic weight gain, serum electrolytes, intradialytic saline administration, missed treatments, hospitalizations, medication, inflammatory markers, etc. All subjects included in the final dataset will be matched with dialysis patients receiving treatment in other dialysis clinics of the Renal Research Institute who were not subject to the operational change. This will lead to the development of a matched cohort of equal size unexposed to dialysate to serum sodium alignment.

The analysis is planned to investigate treatment effects, and test the effects of dialysate to serum sodium alignment for interactions and associations between those laboratory and clinical parameters. The extent and magnitude of sodium alignment (the operational change) will also be assessed.

Study Type

Observational

Enrollment (Actual)

148

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

  • United States
    • New York
      • New York, New York, United States, 10128
        • Renal Research Institute

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 to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All subjects on hemodialysis

Description

Inclusion Criteria:

  • Subjects on hemodialysis

Exclusion Criteria:

  • None

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Subjects undergoing sodium alignment
Dialysate and serum sodium concentration aligned
Other: Dialysate and serum sodium concentration aligned
Subjects not undergoing sodium alignment
Dialysate and serum sodium concentration not aligned

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Interdialytic weight gain
Time Frame: Each dialysis treatment (3x per week) - 2 years of treatment data
Each dialysis treatment (3x per week) - 2 years of treatment data
Pre-dialysis Blood Pressure
Time Frame: Each dialysis treatment (3x per week)- 2 years of treatment data
Each dialysis treatment (3x per week)- 2 years of treatment data

Secondary Outcome Measures

Outcome Measure
Time Frame
Hospitalization rate and number of days
Time Frame: Per occurence during the entire follow-up period of 2 years
Per occurence during the entire follow-up period of 2 years

Other Outcome Measures

Outcome Measure
Time Frame
Body weight
Time Frame: Each treatment (3x per week)- 2 years of treatment data
Each treatment (3x per week)- 2 years of treatment data
Serum electrolytes
Time Frame: Each treatment (3x per week)- 2 years of treatment data
Each treatment (3x per week)- 2 years of treatment data
Intradialytic saline administration
Time Frame: Per occurance
Per occurance
Inflammatory markers
Time Frame: Each treatment (3x per week)- 2 years of treatment data
Each treatment (3x per week)- 2 years of treatment data
Medications
Time Frame: Per occurance
Per occurance
Missed treatments
Time Frame: Per occurance
Per occurance

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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.

General Publications

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

May 1, 2011

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

March 13, 2013

First Submitted That Met QC Criteria

April 1, 2013

First Posted (Estimate)

April 5, 2013

Study Record Updates

Last Update Posted (Estimate)

February 24, 2016

Last Update Submitted That Met QC Criteria

February 23, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 053-11

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.

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