Effects of Simple Sodium Alignment on Clinical Outcomes

Completed

• Conditions: Complication of Hemodialysis
• Interventions: Other: Dialysate and serum sodium concentration aligned

• Registration Number: NCT01825590
• Lead Sponsor: Renal Research Institute

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.

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 Timeline

• Study Start: 2011-05
• Study First Submitted: 2013-03-13
• Study First Submitted QC: 2013-04-01
• Study First Posted: 2013-04-05
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-23
• Last Update Posted: 2016-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

Inclusion Criteria

• Subjects on hemodialysis

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects undergoing sodium alignment	Dialysate and serum sodium concentration aligned	Dialysate and serum sodium concentration aligned

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Hospitalization rate and number of days	Per occurence during the entire follow-up period of 2 years

Trial Locations

Locations (1)

Renal Research Institute; 🇺🇸 New York, New York, United States