Effects of Simple Sodium Alignment on Clinical Outcomes

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Complication of Hemodialysis

Intervention / Treatment
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* Other: Dialysate and serum sodium concentration aligned


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects on hemodialysis Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 88 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects undergoing sodium alignment<br>Dialysate and serum sodium concentration aligned | Other: Dialysate and serum sodium concentration aligned<br> <br> |
| Subjects not undergoing sodium alignment<br>Dialysate and serum sodium concentration not aligned | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemodialysis, dialysate and serum sodium