Liberalizing Potassium Restrictions in Patients Receiving Hemodialysis
A legfontosabb adatok
- Hol
- Toronto (Kanada)A helyszín megnézése
AI-kivonat: kiket keres a vizsgálat
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A vizsgálat olyan felnőtteket keres, akik több mint 3 hónapja kapnak hemodialízist, és az elmúlt évben legalább egyszer magas volt a vérük káliumszintje.
- Életkor
- 18 éves vagy idősebb
- Nem
- Mindkét nem
- A betegség stádiuma
- Több mint 3 hónapja tartó fenntartó hemodialízis, hetente legalább 3 alkalommal
- Korábbi kezelés
- A csatlakozás előtti 7 napban nem kaphatott káliumkötő szert
- Biomarker vagy leletérték
- Az elmúlt 12 hónapban legalább 1 vér káliumérték 5,0 mmol/L felett; az elmúlt 3 hónap átlagos káliumértéke nem lehet 6,0 mmol/L felett
A részvétel fő kizáró okai
- Káliumkötő szer az elmúlt 7 napban
- Az elmúlt 3 hónap átlagos karbamidcsökkenési aránya 65% alatt
- Az elmúlt hónapban több mint 2 kihagyott dialízis
- Nyelési vagy emésztőrendszeri panasz, amely akadályozza a megfelelő táplálkozást
- Olyan intézményben él, ahol az étkezést biztosítják, például tartós ápolást nyújtó otthonban
Ez a vizsgálat csak dializált résztvevőket keres. A regiszter mondata, amelyen ez alapul: Age ≥18 years on maintenance HD >3 months
Gépi kiolvasás: 2026. november 9.
Helyszínek itt: Kanada
- St. Michael's Hospital, Unity Health TorontoToronto, KanadaNo longer taking part
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
A vizsgálat adatai
- Ki végzi
- University of Ontario Institute of Technology
- Azonosító
- NCT07772856
- A regiszteradat frissítve
- 2026. augusztus 19.
- Eredeti leírás
People with end-stage kidney disease who receive hemodialysis are often told to strictly limit foods high in potassium, such as fruits, vegetables, legumes, nuts, and whole grains. This advice is intended to prevent high blood potassium levels (hyperkalemia), which can cause dangerous heart rhythm problems. However, these restrictions can make eating difficult, reduce diet quality, and lower quality of life. New research suggests that not all sources of potassium affect the body in the same way. Potassium added to highly processed foods is more easily absorbed than potassium naturally found in whole foods like fruits and vegetables. Large studies have found little evidence that eating potassium-rich whole foods increases blood potassium levels in people on dialysis. Clinical guidelines are beginning to shift, but no high-quality clinical trial has tested whether a more flexible, food-based approach is safe for people receiving hemodialysis. This study will compare two dietary approaches in 148 adults on hemodialysis: the usual low potassium diet and a "liberalized" potassium diet that encourages minimally processed foods while limiting highly processed foods with potassium additives. Participants will receive dietitian support and grocery assistance for 12 weeks. The investigators will closely monitor blood potassium levels to ensure safety. The investigators will also examine whether the liberalized diet is as safe as standard care, and whether it improves diet quality and quality of life. The investigators will also study factors that influence the participant's ability to follow the diet in real-world settings. If safe, this approach could reduce unnecessary food restrictions, improve diet quality, and enhance quality of life for people receiving hemodialysis, while maintaining patient safety.A teljes eredeti leírásKevesebb
Evaluating the Safety and Acceptability of a Liberalized Potassium Diet in Maintenance Hemodialysis Recipients: A Randomized Controlled Trial (LIBERATE K-HD)
People with end-stage kidney disease who receive hemodialysis are often told to strictly limit foods high in potassium, such as fruits, vegetables, legumes, nuts, and whole grains. This advice is intended to prevent high blood potassium levels (hyperkalemia), which can cause dangerous heart rhythm problems. However, these restrictions can make eating difficult, reduce diet quality, and lower quality of life. New research suggests that not all sources of potassium affect the body in the same way. Potassium added to highly processed foods is more easily absorbed than potassium naturally found in whole foods like fruits and vegetables. Large studies have found little evidence that eating potassium-rich whole foods increases blood potassium levels in people on dialysis. Clinical guidelines are beginning to shift, but no high-quality clinical trial has tested whether a more flexible, food-based approach is safe for people receiving hemodialysis. This study will compare two dietary approaches in 148 adults on hemodialysis: the usual low potassium diet and a "liberalized" potassium diet that encourages minimally processed foods while limiting highly processed foods with potassium additives. Participants will receive dietitian support and grocery assistance for 12 weeks. The investigators will closely monitor blood potassium levels to ensure safety. The investigators will also examine whether the liberalized diet is as safe as standard care, and whether it improves diet quality and quality of life. The investigators will also study factors that influence the participant's ability to follow the diet in real-world settings. If safe, this approach could reduce unnecessary food restrictions, improve diet quality, and enhance quality of life for people receiving hemodialysis, while maintaining patient safety.
Bevonási feltételek: Age ≥18 years on maintenance HD >3 months; ≥1 serum potassium concentration >5.0 mmol/L on routine bloodwork in past 12 months; Able to provide consent.
Kizáró feltételek: >2 missed scheduled dialysis sessions in the previous month; Patients receiving <3 hemodialysis sessions per week (ex/ incremental dialysis); Unable to comply with study procedures due to cognitive impairment, language barrier or for any additional reason specified by the attending clinician; Treatment with potassium binders within the preceding 7 days; Average serum potassium concentration >6.0 mmol/L over the past 3 months; HbA1c >11%; Average Urea reduction rate over the past 3 months <65%; Swallowing difficulties or other GI issues preventing adequate intake; Residing in an institutional setting (e.g., Long-term care homes) where meals are provided.