The Reducing Adverse Outcomes in Dialysis by Adjusting the pRescription for Dialysate Potassium Trial

Not Applicable

Not yet recruiting

• Conditions: End Stage Kidney Disease

• Registration Number: NCT07051447
• Lead Sponsor: NYU Langone Health

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-26
• Study First Submitted QC: 2025-06-26
• Last Update Submitted: 2025-06-26
• Study First Posted: 2025-07-04
• Last Update Posted: 2025-07-04
• Study Start: 2025-08-01
• Primary Completion: 2029-02-01
• Study Completion: 2029-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Incidence Rate of Post-HD Hyperkalemia Incidence Rate	Up to Week 24	Hyperkalemia is defined as K≥ 6.4 mEq/L.
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 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.