About this trial
This will be a randomized controlled pilot trial comparing usual care to a precision approach to dialysis potassium prescribing. The precision approach will incorporate point of care testing of blood potassium concentration prior to each dialysis session and adjustment of the dialysate K prescription with a blood-dialysate K gradient minimization strategy (PKRxHD).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Undergoing in-center, 3x/weekly HD for treatment of end-stage kidney disease (ESKD) for at least 90 days
Age at least 21 years
Prescribed HD time up to 15 hours/ week
Disqualifiers
Incarcerated
Life expectancy of 1 year or less
Kidney transplant, transition to home dialysis, or transfer to non-participating HD unit anticipated within 6 months or less
Cognitive condition that precludes consent
Trial design
Parallel
Treatments tested in this trial
PKRxHD
Other interventionThe precision approach will incorporate point of care testing of blood potassium concentration prior to each dialysis session and adjustment of the dialysate K prescription with a blood-dialysate K gradient minimization strategy (PKRxHD).
Dialysis
Procedure/SurgeryStandard of care dialysis.
Treatment groups
Trial outcomes
Primary outcomes
Intervention Adherence
Measured as the proportion of hemodialysis (HD) treatments in the experimental arm completed per protocol with both pre-HD point of care testing and appropriate adjustment of the dialysate prescription.
Recruitment Feasibility
Measured as the proportion of eligible patients enrolled successfully.
Incidence Rate of Pre-HD Hyperkalemia
Hyperkalemia is defined as K≥ 6.4 mEq/L.
Post-HD Recovery Time
Measured as the average time to recovery following each HD session.
Secondary outcomes
Incidence Rate of Post-HD Hyperkalemia Incidence Rate
Hyperkalemia is defined as K≥ 6.4 mEq/L.
Incidence Rate of Moderate Hyperkalemia
Hyperkalemia is defined as K≥ 3.0 mEq/L.
Incidence Rate of Peri-Dialytic Cramping
Incidence Rate of Intradialytic Hypotension
Intradialytic hypotension will be defined as the proportion of HD sessions with intradialytic systolic blood pressure\<90 mmHg, as this definition best captures associations with mortality according to current guidelines.
Locations
Sponsors and contacts
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NYU Langone Health
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
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