Clinical trial NCT05558267: Potassium Containing Salt-Substitute in Hemodialysis-Dependent End Stage Kidney Disease
Official title: A Randomized, Pilot, Double-Blind Crossover Trial of a Potassium Containing Salt-Substitute in Hemodialysis-Dependent End Stage Kidney Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: End Stage Kidney Disease
Keywords: Potassium-Containing Salt Substitute
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2022-09-28
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Receiving outpatient maintenance HD therapy.
2. Age ≥ 21 years.
3. Negative serum pregnancy test for women of child-bearing capacity. Childbearing capacity will be defined by report of menstruation within ≤ 6 months.

Exclusion Criteria:

1. Currently incarcerated.
2. Insufficient capacity for informed consent.
3. Non-hemolyzed serum potassium concentration \>6.0 mEq/L within ≤30 days.
4. Unscheduled HD for hyperkalemia within ≤30 days.
5. Attendance at ≤10 of last 13 scheduled OP HD sessions.
6. Co-habiting family member with known hyperkalemia.
7. Co-habiting family with ≥stage 3b chronic kidney disease or chronic kidney disease of unknown severity.
8. Hemoglobin \< 8.0 mg/dL.
9. Use of other potassium supplements.

Primary outcomes:
measure: Change in Serum Potassium Concentration During First Treatment Period
timeFrame: Day 1, Day 16
measure: Change in Serum Potassium Concentration During Second Treatment Period
timeFrame: Day 36, Day 52
Secondary outcomes:
measure: Number of Participants Presenting with Severe Hyperkalemia During First Treatment Period
timeFrame: Up to Day 16
measure: Number of Participants Presenting with Severe Hyperkalemia During Second Treatment Period
timeFrame: From Day 36 up to Day 52
measure: Number of Participants Presenting with Moderate Hyperkalemia
timeFrame: Up to Day 52
measure: Mean Potassium Concentration During First Treatment Period
timeFrame: Up to Day 16
measure: Mean Potassium Concentration During Second Treatment Period
timeFrame: From Day 36 up to Day 52
measure: Change in Ambulatory Systolic Blood Pressure During First Treatment Period
timeFrame: Day 1, Day 16
measure: Change in Ambulatory Systolic Blood Pressure During Second Treatment Period
timeFrame: Day 36, Day 52
measure: Mean Pre-Dialysis Systolic Blood Pressure During First Treatment Period
timeFrame: Up to Day 16
measure: Mean Pre-Dialysis Systolic Blood Pressure During Second Treatment Period
timeFrame: From Day 36 up to Day 52.
measure: Number of Participants Presenting with Intradialytic Hypotension
timeFrame: Up to Day 52
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Medical Center
name: David Charytan, MD MSc
role: PRINCIPAL_INVESTIGATOR
References: