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Not yet recruiting NCT07051447

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

No phase Interventional End Stage Kidney Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PKRxHD, Dialysis.
Who it may be relevant to
Registry conditions: End Stage Kidney Disease. Basic parameters: from 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Reducing Adverse Outcomes in Dialysis by Adjusting the pRescription for Dialysate Potassium Trial (RADAR-K): A Randomized, Controlled, Pilot Trial Comparing Usual Care to a Precision Approach to Dialysis Potassium Prescribing.

Overview

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

  • Other PKRxHD
    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).
  • Procedure Dialysis
    Standard of care dialysis.

Primary outcome measures

  • Intervention Adherence [Time frame: Up to Week 24]
  • Recruitment Feasibility [Time frame: Baseline]
  • Incidence Rate of Pre-HD Hyperkalemia [Time frame: Baseline]
  • Post-HD Recovery Time [Time frame: Up to Week 24]
Secondary outcome measures (4)
  • Incidence Rate of Post-HD Hyperkalemia Incidence Rate [Time frame: Up to Week 24]
  • Incidence Rate of Moderate Hyperkalemia [Time frame: Up to Week 24]
  • Incidence Rate of Peri-Dialytic Cramping [Time frame: Up to Week 24]
  • Incidence Rate of Intradialytic Hypotension [Time frame: Up to Week 24]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07051447 · 24-01766

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗