Effects of Simple Sodium Alignment on Clinical Outcomes

NCT ID: NCT01825590

Last Updated: 2016-02-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 148 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2014-08-31

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.

Conditions

Complication of Hemodialysis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Subjects undergoing sodium alignment

Dialysate and serum sodium concentration aligned

Dialysate and serum sodium concentration aligned

Intervention Type: OTHER

Subjects not undergoing sodium alignment

Dialysate and serum sodium concentration not aligned

No interventions assigned to this group

Interventions

Dialysate and serum sodium concentration aligned

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Subjects on hemodialysis

Exclusion Criteria

• None

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 88 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Renal Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Kotanko, MD

Role: PRINCIPAL_INVESTIGATOR

Renal Research Institute

Locations

Renal Research Institute

New York, New York, United States

Countries

United States

References

Raimann JG, Ficociello LH, Usvyat LA, Zhang H, Pacelli L, Moore S, Sheppard P, Xiao Q, Wang Y, Mullon C, Balter P, Sullivan T, Kotanko P. Effects of dialysate to serum sodium (Na+) alignment in chronic hemodialysis (HD) patients: retrospective cohort study from a quality improvement project. BMC Nephrol. 2018 Apr 2;19(1):75. doi: 10.1186/s12882-018-0870-0.

Reference Type: DERIVED

PMID: 29609536 (View on PubMed)

Other Identifiers

053-11

Identifier Type: -

Identifier Source: org_study_id