Potassium Containing Salt-Substitute in Hemodialysis-Dependent 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: Standard Table Salt, Salt Substitute.
- 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
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized, Pilot, Double-Blind Crossover Trial of a Potassium Containing Salt-Substitute in Hemodialysis-Dependent End Stage Kidney Disease
Overview
16 individuals with hemodialysis-dependent end stage kidney disease will receive 16 days of a potassium-containing salt-substitute and 16 days of standard table salt in random order. There will be a 19 day wash out period between the salt-substitute and table salt periods. Potassium concentration will be measured bi-weekly prior to HD each week during intervention. The primary endpoint will be the change in potassium from baseline. Additional measurements will include assessment of dietary intake, ambulatory blood pressure, occurrence of peri-dialytic symptoms, and per-dialytic vital signs.
Interventions
- Dietary supplement Standard Table Salt
Standard Table Salt is administered orally. It is transferred to unmarked saltshakers by non-blinded research coordinators. The unmarked saltshaker is delivered to the participant during dialysis. - Dietary supplement Salt Substitute
Salt Substitute is available as a crystalized powder. It substitutes potassium chloride for sodium chloride, and thus contains about 50% less sodium than standard table salt. Salt Substitute is administered orally. It is transferred to unmarked saltshakers by non-blinded research coordinators. The unmarked saltshaker is delivered to the participant during dialysis.
Primary outcome measures
- Change in Serum Potassium Concentration During First Treatment Period [Time frame: Day 1, Day 16]
- Change in Serum Potassium Concentration During Second Treatment Period [Time frame: Day 36, Day 52]
Secondary outcome measures (10)
- Number of Participants Presenting with Severe Hyperkalemia During First Treatment Period [Time frame: Up to Day 16]
- Number of Participants Presenting with Severe Hyperkalemia During Second Treatment Period [Time frame: From Day 36 up to Day 52]
- Number of Participants Presenting with Moderate Hyperkalemia [Time frame: Up to Day 52]
- Mean Potassium Concentration During First Treatment Period [Time frame: Up to Day 16]
- Mean Potassium Concentration During Second Treatment Period [Time frame: From Day 36 up to Day 52]
- Change in Ambulatory Systolic Blood Pressure During First Treatment Period [Time frame: Day 1, Day 16]
- Change in Ambulatory Systolic Blood Pressure During Second Treatment Period [Time frame: Day 36, Day 52]
- Mean Pre-Dialysis Systolic Blood Pressure During First Treatment Period [Time frame: Up to Day 16]
- Mean Pre-Dialysis Systolic Blood Pressure During Second Treatment Period [Time frame: From Day 36 up to Day 52.]
- Number of Participants Presenting with Intradialytic Hypotension [Time frame: Up to Day 52]
Eligibility criteria
Inclusion criteria
- Receiving outpatient maintenance HD therapy.
- Age ≥ 21 years.
- Negative serum pregnancy test for women of child-bearing capacity. Childbearing capacity will be defined by report of menstruation within ≤ 6 months.
Exclusion criteria
- Currently incarcerated.
- Insufficient capacity for informed consent.
- Non-hemolyzed serum potassium concentration >6.0 mEq/L within ≤30 days.
- Unscheduled HD for hyperkalemia within ≤30 days.
- Attendance at ≤10 of last 13 scheduled OP HD sessions.
- Co-habiting family member with known hyperkalemia.
- Co-habiting family with ≥stage 3b chronic kidney disease or chronic kidney disease of unknown severity.
- Hemoglobin < 8.0 mg/dL.
- Use of other potassium supplements.
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
- Crossover
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- NYU Langone Health — New York
Identifiers
NCT: NCT05558267 · 22-00769