Beviser for kaliumrestriktion i hæmodialyse (EvoKe-HD)
EvoKe-HD is a pilot randomized controlled trial to assess the feasibility and potential for efficacy of a novel dietary approach to hyperkalemia. Contrary to the traditional recommendations limiting the intake of high-potassium whole foods, such as fruits and vegetables, the investigators propose to switch the focus to foods containing potassium that is readily absorbed by the body (high bioavailability), such as potassium from additives, processed meats, milk, fruit juices and sugary drinks.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Sixty adults receiving hemodialysis treatments with blood potassium levels ≥ 5.2 mmol/L on two occasions or more in the past three months will be randomly assigned to either the novel dietary counselling or the traditional approach. Both groups will meet with the renal dietician again once a month for 20 to 30 minutes, but the content of the recommendations will be different. The intervention and follow-up period will last three months. The investigators will record pre-dialysis potassium, bicarbonate, phosphorus, calcium and parathormone levels, blood pressure, volume status, hospitalizations, medication, and dialysis prescription changes monthly and assess nutritional status and satisfaction with food at the beginning and at the end of the study.
The study will be successful if 30% or more of the eligible patients agree to participate and complete the 3-month assessment.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Quebec
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Montreal, Quebec, Canada, H4J 1C5
- CIUSSS du Nord-de-l'Île-de-Montréal
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- ≥18 years or older
- Receiving hemodialysis 3 times/week for ≥ 3 months
- Has at least two pre-dialysis serum potassium levels ≥5.2 mmol/L on any analysis in the past 3 months OR the most recent pre-dialysis serum potassium value ≥ 4.6 mmol/L and is currently prescribed a potassium-binding agent at a regular frequency (defined as ≥ once per week).
- Can speak and understand French or English
- Has not missed more than 1 dialysis session in the previous 3 months.
- Is capable of providing informed consent.
Exclusion Criteria:
- Is not expected to survive beyond 6 months
- Does not control their dietary intake (e.g., residents of high-dependency nursing homes)
- Significant cognitive impairment precluding understanding of the dietary recommendations.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Restriction high bioavailability potassium sources
Participants will be asked to identify and avoid food items with potassium additives by revising the ingredient lists of the grocery products they consume. They will also be asked to reduce two sources of high bioavailability potassium, such as meat, milk, fruit juices, processed potatoes or coffee. |
Participants will be asked to identify and avoid food items with potassium additives by revising the ingredient lists of the grocery products they consume. They will also be asked to reduce two sources of high bioavailability potassium, such as meat, milk, fruit juices, processed potatoes or coffee. |
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Aktiv komparator: Control
Participants will be asked to reduce the intake of food items with high total potassium content. A list of moderate-to-high potassium food items will be provided to the participants. |
Participants will be asked to reduce the intake of food items with high total potassium content. A list of moderate-to-high potassium food items will be provided to the participants. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Ændring i gennemsnitligt midt-uge predialyse kaliumniveau i løbet af undersøgelsesperioden
Tidsramme: 3 måneder
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3 måneder
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Percentage of prevalent dialysis patients recruited and retained for 3 months
Tidsramme: 3 months
|
Primary feasibility outcome |
3 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Gennemsnitlig månedlig midtuge præ-dialyse serumkaliumniveau (mmol/L)
Tidsramme: 3 måneder
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3 måneder
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Peak serum kalium over studieperioden
Tidsramme: 3 måneder
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3 måneder
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|
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Antallet af hyperkalæmi-hændelser (≥5,6 mmol/L) og svær hyperkalæmi-hændelser (>6 mmol/L)
Tidsramme: 3 måneder
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3 måneder
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Antal dialysesessioner med dialysatkoncentration < 2 mmol/L
Tidsramme: 3 måneder
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3 måneder
|
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Antal patienter, for hvilke kaliumdialysatkoncentrationen blev hævet eller sænket (med ≥0,5 mmol/L)
Tidsramme: 3 måneder
|
3 måneder
|
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Total dosis af kaliumbindere (g) i løbet af undersøgelsesperioden
Tidsramme: 3 måneder
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3 måneder
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Antal deltagere, der tager kaliumbindere efter 3 måneder
Tidsramme: 3 måneder
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3 måneder
|
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Antal portioner/dag af fødevarer med høj kaliumbiologisk tilgængelighed (kød, mejeriprodukter, saft, kartofler)
Tidsramme: 3 måneder
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3 måneder
|
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Antal portioner/dag af madvarer med moderat til højt totalt kaliumindhold
Tidsramme: 3 måneder
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3 måneder
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Forhold mellem planteprotein- og dyreproteinindtag (g/g)
Tidsramme: 3 måneder
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3 måneder
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Albuminniveauer (g/L)
Tidsramme: 3 måneder
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3 måneder
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Body mass index (kg/m2)
Tidsramme: 3 måneder
|
3 måneder
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Vægtændring (kg)
Tidsramme: 3 måneder
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3 måneder
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Gennemsnitlig månedlig midtuges serumfosfatniveau før dialyse (mmol/L)
Tidsramme: 3 måneder
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3 måneder
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Gennemsnitlig månedlig midtuge præ-dialyse serum calcium niveau (mmol/L)
Tidsramme: 3 måneder
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3 måneder
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Præ-dialyse serum parathyreoideahormonniveau (pmol/L)
Tidsramme: 3 måneder
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3 måneder
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Månedlige gennemsnitlige serum bicarbonatniveauer (mmol/L)
Tidsramme: 3 måneder
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3 måneder
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Interdialyse vægtstigning (kg/dag)
Tidsramme: 3 måneder
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3 måneder
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1-uges gennemsnitlig præ-dialyse blodtryk (mmHg)
Tidsramme: 3 måneder
|
3 måneder
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Ratio of the number of randomized participants over the number of screened participants randomized
Tidsramme: 3 months
|
Secondary feasibility outcome |
3 months
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Number of participants recruited 12 months into the trial
Tidsramme: 3 months
|
Secondary feasibility outcome |
3 months
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Percentage of randomized participants who report having understood the dietary recommendations well or very well using a 1-7 Likert scale with anchors
Tidsramme: 3 months
|
Secondary feasibility outcome |
3 months
|
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Percentage of randomized participants who judge the intervention to be acceptable using a 1-7 Likert scale with anchors
Tidsramme: 3 months
|
Secondary feasibility outcome |
3 months
|
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Healthy diet index 2020
Tidsramme: 3 months
|
Include 13 components that reflect the key recommendations in the Dietary Guidelines for Americans, 2020-2025. The maximum score is 100. |
3 months
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Mediterranean diet score
Tidsramme: 3 months
|
0 to 100 score; higher score represents a better adherence to the Mediterranean diet |
3 months
|
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Mediterranean-diet scale
Tidsramme: 3 months
|
Score from 0 (minimal adherence to the traditional Mediterranean diet) to 9 (maximal adherence) |
3 months
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Subjective global assessment
Tidsramme: 3 months
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Standardized subjective assessment of nutritional status performed by a dietitian. Final rating is either Well-nourished, Mildly/moderately malnourished or Severely malnourished with or without cachexia and/or sarcopenia. |
3 months
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Normalized protein nitrogen appearance (g/kg/day)
Tidsramme: 3 months
|
calculated from urea reduction ratio |
3 months
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Satisfaction with food-related life
Tidsramme: 3 months
|
5-item scale, total score range 0 to 100, higher score represents higher satisfaction with food |
3 months
|
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Self-perceived impact on diet
Tidsramme: 3 months
|
"I changed my diet in the past 3 months based on the advice I received from the renal dietitian" (1-7 Likert scale with anchors) |
3 months
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Self-perceived compliance with the dietary recommendations
Tidsramme: 3 months
|
"I am following the diet recommended by the renal dietitian" (1-7 Likert scale with anchors) |
3 months
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Dødelighed af alle årsager
Tidsramme: 3 måneder
|
3 måneder
|
|
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Major cardiovascular events
Tidsramme: 3 months
|
Composite of nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death |
3 months
|
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Standardised Outcomes in NephroloGy fatigue measure
Tidsramme: 3 months
|
3 questions answered on a 4-points Likert scale. The results of each question (rated 0 to 3) is summed up to obtain to total score (range 0 to 9) |
3 months
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2024-2643
Plan for individuelle deltagerdata (IPD)
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