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OpenTrials
Completed

NCT Number: NCT01825590

Effects of Simple Sodium Alignment on Clinical Outcomes

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.

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Key information

Conditions

Complication of Hemodialysis

Age range

18 year–88 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Renal Research Institute

New York, 10128, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects on hemodialysis

Exclusion criteria

  • None

Treatment and study plan

Dialysate and serum sodium concentration aligned

Other

Primary outcomes

  1. Interdialytic weight gain

    Time frame: Each dialysis treatment (3x per week) - 2 years of treatment data

  2. Pre-dialysis Blood Pressure

    Time frame: Each dialysis treatment (3x per week)- 2 years of treatment data

Secondary outcomes

  1. Hospitalization rate and number of days

    Time frame: Per occurence during the entire follow-up period of 2 years

Other outcomes

  1. Body weight

    Time frame: Each treatment (3x per week)- 2 years of treatment data

  2. Serum electrolytes

    Time frame: Each treatment (3x per week)- 2 years of treatment data

  3. Intradialytic saline administration

    Time frame: Per occurance

  4. Inflammatory markers

    Time frame: Each treatment (3x per week)- 2 years of treatment data

  5. Medications

    Time frame: Per occurance

  6. Missed treatments

    Time frame: Per occurance

Sponsors and collaborators

Lead sponsor

Renal Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Apr 5, 2013
Registry last updated
Feb 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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