End Stage Kidney Disease
Conditions
Brief summary
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).
Interventions
OTHERPKRxHD
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).
PROCEDUREDialysis
Standard of care dialysis.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * Severe anemia (hemoglobin \< 8.0 g/dL) within 30 days * K concentration of 7.0 mEq/L or more within 60 days * Pregnant women * Women of childbearing potential actively trying to conceive unwilling to use contraception * Participation in other interventional studies within 30 days prior to enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intervention Adherence | Up to Week 24 | 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 | Baseline | Measured as the proportion of eligible patients enrolled successfully. |
| Incidence Rate of Pre-HD Hyperkalemia | Baseline | Hyperkalemia is defined as K≥ 6.4 mEq/L. |
| Post-HD Recovery Time | Up to Week 24 | Measured as the average time to recovery following each HD session. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence Rate of Moderate Hyperkalemia | Up to Week 24 | Hyperkalemia is defined as K≥ 3.0 mEq/L. |
| Incidence Rate of Peri-Dialytic Cramping | Up to Week 24 | — |
| Incidence Rate of Post-HD Hyperkalemia Incidence Rate | Up to Week 24 | Hyperkalemia is defined as K≥ 6.4 mEq/L. |
| Incidence Rate of Intradialytic Hypotension | Up to Week 24 | 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. |
Contacts
Primary ContactDavid Charytan, MD
Backup ContactZoe Rimler
Outcome results
None listed