Effects of Simple Sodium Alignment on Clinical Outcomes
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | 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 |
Outcome Measures
Primary Outcome Measures
- 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
- Hospitalization rate and number of days [Per occurence during the entire follow-up period of 2 years]
Other Outcome Measures
- Body weight [Each treatment (3x per week)- 2 years of treatment data]
- Serum electrolytes [Each treatment (3x per week)- 2 years of treatment data]
- Intradialytic saline administration [Per occurance]
- Inflammatory markers [Each treatment (3x per week)- 2 years of treatment data]
- Medications [Per occurance]
- Missed treatments [Per occurance]
Eligibility Criteria
Criteria
Inclusion Criteria:
- Subjects on hemodialysis
Exclusion Criteria:
- None
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Renal Research Institute | New York | New York | United States | 10128 |
Sponsors and Collaborators
- Renal Research Institute
Investigators
- Principal Investigator: Peter Kotanko, MD, Renal Research Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 053-11