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Effects of Simple Sodium Alignment on Clinical Outcomes

R

Renal Research Institute

Status

Completed

Conditions

Complication of Hemodialysis

Treatments

Other: Dialysate and serum sodium concentration aligned

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

148 patients

Sex

All

Ages

18 to 88 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Subjects on hemodialysis

Exclusion criteria

  • None

Trial design

148 participants in 2 patient groups

Subjects undergoing sodium alignment
Description:
Dialysate and serum sodium concentration aligned
Treatment:
Other: Dialysate and serum sodium concentration aligned
Subjects not undergoing sodium alignment
Description:
Dialysate and serum sodium concentration not aligned

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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