Effects of Simple Sodium Alignment on Clinical Outcomes
1 other identifier
observational
148
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2011
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 13, 2013
CompletedFirst Posted
Study publicly available on registry
April 5, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedFebruary 24, 2016
February 1, 2016
3.3 years
March 13, 2013
February 23, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Hospitalization rate and number of days
Per occurence during the entire follow-up period of 2 years
Other Outcomes (6)
Body weight
Each treatment (3x per week)- 2 years of treatment data
Serum electrolytes
Each treatment (3x per week)- 2 years of treatment data
Intradialytic saline administration
Per occurance
- +3 more other outcomes
Study Arms (2)
Subjects undergoing sodium alignment
Dialysate and serum sodium concentration aligned
Subjects not undergoing sodium alignment
Dialysate and serum sodium concentration not aligned
Interventions
Eligibility Criteria
All subjects on hemodialysis
You may qualify if:
- Subjects on hemodialysis
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Renal Research Institute
New York, New York, 10128, United States
Related Publications (1)
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.
PMID: 29609536DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Kotanko, MD
Renal Research Institute
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2013
First Posted
April 5, 2013
Study Start
May 1, 2011
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
February 24, 2016
Record last verified: 2016-02