Ignite Creation Date:
2024-05-06 @ 7:46 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06120608
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-15
First Post:
2023-10-18
Brief Title:
Evidence for Potassium Restriction in Hemodialysis
Sponsor:
Centre Integre Universitaire de Sante et Services Sociaux du Nord de lile de Montreal
Organization:
Centre Integre Universitaire de Sante et Services Sociaux du Nord de lile de Montreal
Study Overview
Official Title:
Evidence for Potassium Restriction in Hemodialysis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EvoKe-HD
Brief Summary:
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
Detailed Description:
Sixty adults receiving hemodialysis treatments with blood potassium levels 52 mmolL 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 six 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 6-month assessment
The study will be successful if 30 or more of the eligible patients agree to participate and complete the 6-month assessment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None