Effects of Simple Sodium Alignment on Clinical Outcomes

Complication of Hemodialysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01825590
• Other study ID #: 053-11
• Status: Completed
• Phase: N/A
• First received: March 13, 2013
• Last updated: February 23, 2016
• Start date: May 2011
• Est. completion date: August 2014

Study information

• Verified date: February 2016
• Source: Renal Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 88 Years

Eligibility

Inclusion Criteria:

• Subjects on hemodialysis

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Complication of Hemodialysis

Intervention

Other:
• Dialysate and serum sodium concentration aligned

Locations

Country	Name	City	State
United States	Renal Research Institute	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Renal Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Body weight		Each treatment (3x per week)- 2 years of treatment data	No
Other	Serum electrolytes		Each treatment (3x per week)- 2 years of treatment data	No
Other	Intradialytic saline administration		Per occurance	No
Other	Inflammatory markers		Each treatment (3x per week)- 2 years of treatment data	No
Other	Medications		Per occurance	No
Other	Missed treatments		Per occurance	No
Primary	Interdialytic weight gain		Each dialysis treatment (3x per week) - 2 years of treatment data	No
Primary	Pre-dialysis Blood Pressure		Each dialysis treatment (3x per week)- 2 years of treatment data	No
Secondary	Hospitalization rate and number of days		Per occurence during the entire follow-up period of 2 years	No