Potassium Containing Salt-Substitute in Hemodialysis-Dependent End Stage Kidney Disease

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Pilot, Double-Blind Crossover Trial of a Potassium Containing Salt-Substitute in Hemodialysis-Dependent End Stage Kidney Disease

Conditions
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End Stage Kidney Disease

Intervention / Treatment
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* Dietary Supplement: Standard Table Salt
* Dietary Supplement: Salt Substitute


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard Table Salt, then Salt Substitute<br>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. | Dietary Supplement: Standard Table Salt<br>* 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.<br>* Other names: Morton Standard Table Salt;Dietary Supplement: Salt Substitute<br>* 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.<br>* Other names: Morton Lite Salt;|
| Experimental: Salt Substitute, then Standard Table Salt<br>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. | Dietary Supplement: Standard Table Salt<br>* 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.<br>* Other names: Morton Standard Table Salt;Dietary Supplement: Salt Substitute<br>* 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.<br>* Other names: Morton Lite Salt;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Serum Potassium Concentration During First Treatment Period | Serum potassium concentration expressed in milliequivalents per liter (mEq/L). | Day 1, Day 16 | 
| Change in Serum Potassium Concentration During Second Treatment Period | Serum potassium concentration expressed in mEq/L. | Day 36, Day 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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). | Day 1, Day 16 | 
| Change in Ambulatory Systolic Blood Pressure During Second Treatment Period | Ambulatory systolic blood pressure expressed in mm Hg. | 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. | 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. | 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. | Up to Day 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Potassium-Containing Salt Substitute