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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
20
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.
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.
NYU Langone Health
New York, New York, United States
Change in Serum Potassium Concentration During First Treatment Period
Serum potassium concentration expressed in milliequivalents per liter (mEq/L).
Time frame: Day 1, Day 16
Change in Serum Potassium Concentration During Second Treatment Period
Serum potassium concentration expressed in mEq/L.
Time frame: Day 36, Day 52
Number of Participants Presenting with Severe Hyperkalemia During First Treatment Period
Severe hyperkalemia defined as pre-dialysis potassium levels greater than 6.5 mEq/L. The first treatment period spans from Day 1 to Day 16.
Time frame: Up to Day 16
Number of Participants Presenting with Severe Hyperkalemia During Second Treatment Period
Severe hyperkalemia defined as pre-dialysis potassium levels greater than 6.5 mEq/L. The second treatment period spans from Day 36 to Day 52.
Time frame: From Day 36 up to Day 52
Number of Participants Presenting with Moderate Hyperkalemia
Moderate hyperkalemia defined as pre-dialysis potassium levels greater than 6.0 mEq/L and less than 6.5 mEq/L.
Time frame: Up to Day 52
Mean Potassium Concentration During First Treatment Period
Potassium concentration expressed in mEq/L. The first treatment period spans from Day 1 to Day 16.
Time frame: Up to Day 16
Mean Potassium Concentration During Second Treatment Period
Potassium concentration expressed in mEq/L. The second treatment period spans from Day 36 to Day 52.
Time frame: From Day 36 up to Day 52
Change in Ambulatory Systolic Blood Pressure During First Treatment Period
Ambulatory systolic blood pressure expressed in millimeters of mercury (mm Hg).
Time frame: Day 1, Day 16
Change in Ambulatory Systolic Blood Pressure During Second Treatment Period
Ambulatory systolic blood pressure expressed in mm Hg.
Time frame: Day 36, Day 52
Mean Pre-Dialysis Systolic Blood Pressure During First Treatment Period
Pre-dialysis systolic blood pressure expressed in mm Hg. The first treatment period spans from Day 1 to Day 16.
Time frame: Up to Day 16
Mean Pre-Dialysis Systolic Blood Pressure During Second Treatment Period
Pre-dialysis systolic blood pressure expressed in mm Hg. The second treatment period spans from Day 36 to Day 52.
Time frame: From Day 36 up to Day 52.
Number of Participants Presenting with Intradialytic Hypotension
Intradialytic hypotension defined as a systolic blood pressure of less than 100 mmHg or a systolic blood pressure decrease of greater than 10 mmHg, or a mean arterial pressure decrease of greater than 30 mmHg with or without symptoms.
Time frame: Up to Day 52
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