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Effects of Simple Sodium Alignment on Clinical Outcomes

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01825590
Enrollment
148
Registered
2013-04-05
Start date
2011-05-31
Completion date
2014-08-31
Last updated
2016-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complication of Hemodialysis

Keywords

hemodialysis, dialysate and serum sodium

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.

Interventions

OTHERDialysate and serum sodium concentration aligned

Sponsors

Renal Research Institute
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 88 Years
Healthy volunteers
No

Inclusion criteria

* Subjects on hemodialysis

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frame
Interdialytic weight gainEach dialysis treatment (3x per week) - 2 years of treatment data
Pre-dialysis Blood PressureEach dialysis treatment (3x per week)- 2 years of treatment data

Secondary

MeasureTime frame
Hospitalization rate and number of daysPer occurence during the entire follow-up period of 2 years

Other

MeasureTime frame
Inflammatory markersEach treatment (3x per week)- 2 years of treatment data
Body weightEach treatment (3x per week)- 2 years of treatment data
Missed treatmentsPer occurance
MedicationsPer occurance
Serum electrolytesEach treatment (3x per week)- 2 years of treatment data
Intradialytic saline administrationPer occurance

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026