Potassium Containing Salt-Substitute in Hemodialysis-Dependent End Stage Kidney Disease
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Standard Table Salt, Salt Substitute.
- Кому может быть актуально
- Состояния в реестре: End Stage Kidney Disease. Базовые параметры: от 21 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
A Randomized, Pilot, Double-Blind Crossover Trial of a Potassium Containing Salt-Substitute in Hemodialysis-Dependent End Stage Kidney Disease
Обзор
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.
Вмешательства
- Пищевая добавка 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. - Пищевая добавка 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.
Первичные конечные точки
- Change in Serum Potassium Concentration During First Treatment Period [Срок оценки: Day 1, Day 16]
- Change in Serum Potassium Concentration During Second Treatment Period [Срок оценки: Day 36, Day 52]
Вторичные конечные точки (10)
- Number of Participants Presenting with Severe Hyperkalemia During First Treatment Period [Срок оценки: Up to Day 16]
- Number of Participants Presenting with Severe Hyperkalemia During Second Treatment Period [Срок оценки: From Day 36 up to Day 52]
- Number of Participants Presenting with Moderate Hyperkalemia [Срок оценки: Up to Day 52]
- Mean Potassium Concentration During First Treatment Period [Срок оценки: Up to Day 16]
- Mean Potassium Concentration During Second Treatment Period [Срок оценки: From Day 36 up to Day 52]
- Change in Ambulatory Systolic Blood Pressure During First Treatment Period [Срок оценки: Day 1, Day 16]
- Change in Ambulatory Systolic Blood Pressure During Second Treatment Period [Срок оценки: Day 36, Day 52]
- Mean Pre-Dialysis Systolic Blood Pressure During First Treatment Period [Срок оценки: Up to Day 16]
- Mean Pre-Dialysis Systolic Blood Pressure During Second Treatment Period [Срок оценки: From Day 36 up to Day 52.]
- Number of Participants Presenting with Intradialytic Hypotension [Срок оценки: Up to Day 52]
Критерии участия
Критерии включения
- 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.
Критерии исключения
- 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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Перекрёстный дизайн
- Маскирование
- Двойное слепое
- Основная цель
- Профилактика
Центры проведения
США · 1 центр
- NYU Langone Health — New York
Идентификаторы
NCT: NCT05558267 · 22-00769