Potassium Containing Salt-Substitute in Hemodialysis-Dependent End Stage Kidney Disease
- Conditions
- End Stage Kidney Disease
- Interventions
- Dietary Supplement: Standard Table SaltDietary Supplement: Salt Substitute
- Registration Number
- NCT05558267
- Lead Sponsor
- NYU Langone Health
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 20
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Standard Table Salt, then Salt Substitute Standard Table Salt The two intervention periods will last 16 days with a 19-day washout period in between. During the first 16-day treatment period, participants will receive the Standard Table Salt to use for cooking and as an additive at the table. Participants will then undergo a 19-day washout period. The second 16-day treatment period will immediately follow the washout period. During the second 16-day treatment period, participants will receive the Salt Substitute to use for cooking and as an additive at the table. Participants will be encouraged to replace their use of regular salt with the Standard Table Salt and Salt Substitute. They will be encouraged to reduce their overall intake of salt throughout the study period. There are no restrictions or further instructions regarding timing or dosing. In addition, participants will undergo standard of care hemodialysis (typically 3x/week) and have their blood chemistries measured according to the usual standard of care during the study. Salt Substitute, then Standard Table Salt Standard Table Salt The two intervention periods will last 16 days with a 19-day washout period in between. During the first 16-day treatment period, participants will receive the Salt Substitute to use for cooking and as an additive at the table. Participants will then undergo a 19-day washout period. The second 16-day treatment period will immediately follow the washout period. During the second 16-day treatment period, participants will receive the Standard Table Salt to use for cooking and as an additive at the table. Participants will be encouraged to replace their use of regular salt with the Standard Table Salt and Salt Substitute. They will be encouraged to reduce their overall intake of salt throughout the study period. There are no restrictions or further instructions regarding timing or dosing. In addition, participants will undergo standard of care hemodialysis (typically 3x/week) and have their blood chemistries measured according to the usual standard of care during the study. Standard Table Salt, then Salt Substitute Salt Substitute The two intervention periods will last 16 days with a 19-day washout period in between. During the first 16-day treatment period, participants will receive the Standard Table Salt to use for cooking and as an additive at the table. Participants will then undergo a 19-day washout period. The second 16-day treatment period will immediately follow the washout period. During the second 16-day treatment period, participants will receive the Salt Substitute to use for cooking and as an additive at the table. Participants will be encouraged to replace their use of regular salt with the Standard Table Salt and Salt Substitute. They will be encouraged to reduce their overall intake of salt throughout the study period. There are no restrictions or further instructions regarding timing or dosing. In addition, participants will undergo standard of care hemodialysis (typically 3x/week) and have their blood chemistries measured according to the usual standard of care during the study. Salt Substitute, then Standard Table Salt Salt Substitute The two intervention periods will last 16 days with a 19-day washout period in between. During the first 16-day treatment period, participants will receive the Salt Substitute to use for cooking and as an additive at the table. Participants will then undergo a 19-day washout period. The second 16-day treatment period will immediately follow the washout period. During the second 16-day treatment period, participants will receive the Standard Table Salt to use for cooking and as an additive at the table. Participants will be encouraged to replace their use of regular salt with the Standard Table Salt and Salt Substitute. They will be encouraged to reduce their overall intake of salt throughout the study period. There are no restrictions or further instructions regarding timing or dosing. In addition, participants will undergo standard of care hemodialysis (typically 3x/week) and have their blood chemistries measured according to the usual standard of care during the study.
- Primary Outcome Measures
Name Time Method Change in Serum Potassium Concentration During First Treatment Period Day 1, Day 16 Serum potassium concentration expressed in milliequivalents per liter (mEq/L).
Change in Serum Potassium Concentration During Second Treatment Period Day 36, Day 52 Serum potassium concentration expressed in mEq/L.
- Secondary Outcome Measures
Name Time Method Number of Participants Presenting with Severe Hyperkalemia During First Treatment Period Up to Day 16 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.
Change in Ambulatory Systolic Blood Pressure During First Treatment Period Day 1, Day 16 Ambulatory systolic blood pressure expressed in millimeters of mercury (mm Hg).
Mean Potassium Concentration During First Treatment Period Up to Day 16 Potassium concentration expressed in mEq/L. The first treatment period spans from Day 1 to Day 16.
Mean Potassium Concentration During Second Treatment Period From Day 36 up to Day 52 Potassium concentration expressed in mEq/L. The second treatment period spans from Day 36 to Day 52.
Number of Participants Presenting with Severe Hyperkalemia During Second Treatment Period From Day 36 up to Day 52 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.
Change in Ambulatory Systolic Blood Pressure During Second Treatment Period Day 36, Day 52 Ambulatory systolic blood pressure expressed in mm Hg.
Mean Pre-Dialysis Systolic Blood Pressure During First Treatment Period Up to Day 16 Pre-dialysis systolic blood pressure expressed in mm Hg. The first treatment period spans from Day 1 to Day 16.
Number of Participants Presenting with Moderate Hyperkalemia Up to Day 52 Moderate hyperkalemia defined as pre-dialysis potassium levels greater than 6.0 mEq/L and less than 6.5 mEq/L.
Mean Pre-Dialysis Systolic Blood Pressure During Second Treatment Period From Day 36 up to Day 52. Pre-dialysis systolic blood pressure expressed in mm Hg. The second treatment period spans from Day 36 to Day 52.
Number of Participants Presenting with Intradialytic Hypotension Up to Day 52 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.
Trial Locations
- Locations (1)
NYU Langone Health
🇺🇸New York, New York, United States