Clinical trial NCT01825590: Effects of Simple Sodium Alignment on Clinical Outcomes
Official title: Effects of Simple Sodium Alignment on Short-, Medium- and Long-term Clinical and Laboratory Outcome Measures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Complication of Hemodialysis
Keywords: hemodialysis
dialysate and serum sodium
Lead sponsor: Renal Research Institute
Sponsor class: OTHER
First posted: 2013-04-05
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All subjects on hemodialysis

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.

Eligibility criteria: Inclusion Criteria:

* Subjects on hemodialysis

Exclusion Criteria:

* None

Primary outcomes:
measure: Interdialytic weight gain
timeFrame: Each dialysis treatment (3x per week) - 2 years of treatment data
measure: Pre-dialysis Blood Pressure
timeFrame: Each dialysis treatment (3x per week)- 2 years of treatment data
Secondary outcomes:
measure: Hospitalization rate and number of days
timeFrame: Per occurence during the entire follow-up period of 2 years
Other outcomes:
measure: Body weight
timeFrame: Each treatment (3x per week)- 2 years of treatment data
measure: Serum electrolytes
timeFrame: Each treatment (3x per week)- 2 years of treatment data
measure: Intradialytic saline administration
timeFrame: Per occurance
measure: Inflammatory markers
timeFrame: Each treatment (3x per week)- 2 years of treatment data
measure: Medications
timeFrame: Per occurance
measure: Missed treatments
timeFrame: Per occurance
Locations:
city: New York
country: United States
facility: Renal Research Institute
state: New York
Study officials:
affiliation: Renal Research Institute
name: Peter Kotanko, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.