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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorNYU Langone Health

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • PKRxHD

    Other intervention

    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).

  • Dialysis

    Procedure/Surgery

    Standard of care dialysis.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Precision approach to K Prescription for HD (PKRxHD)Experimental treatment 2 interventions
Group B: Usual CareActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to Week 24
2

Recruitment Feasibility

Measured as the proportion of eligible patients enrolled successfully.

Time frame
Baseline
3

Incidence Rate of Pre-HD Hyperkalemia

Hyperkalemia is defined as K≥ 6.4 mEq/L.

Time frame
Baseline
4

Post-HD Recovery Time

Measured as the average time to recovery following each HD session.

Time frame
Up to Week 24

Secondary outcomes

1

Incidence Rate of Post-HD Hyperkalemia Incidence Rate

Hyperkalemia is defined as K≥ 6.4 mEq/L.

Time frame
Up to Week 24
2

Incidence Rate of Moderate Hyperkalemia

Hyperkalemia is defined as K≥ 3.0 mEq/L.

Time frame
Up to Week 24
3

Incidence Rate of Peri-Dialytic Cramping

Time frame
Up to Week 24
4

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.

Time frame
Up to Week 24

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NYU Langone Health

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

This trial is not recruiting at the moment. You can still explore other options: