POtassium and Cardiac Rhythm Trends in MaintENance HemoDialysis: A Multicenter, Prospective, Observational Study
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 15-006175
NCT ID: NCT02609841
Sponsor Protocol Number: ZS-008
About this study
The purpose of this study is to assess the serum potassium and cardiac rhythm trends in subjects with end stage renal disease (ESRD) who are on 3 times weekly maintenance hemodialysis for at least 60 days.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- Provision of written informed consent
- 18 years of age or older
- Has end stage renal disease and has been stable and compliant (as determined by the investigator) on 3 times weekly maintenance hemodialysis for at least 60 days
- The number of subjects on 3K or higher dialysate will be limited to 60, with the remainder of the subjects on 1K or 2K dialysate
- Dialysate K must be stable for 2 weeks prior to enrollment
- Hemoglobin > 9 g/dL
- Able to undergo peripheral venous sticks for blood draws on inter-dialysis days, or the dialysis/research team is able to use the dialysis access for blood draws on those days
- Subject or subject's caregiver at home can read and understand English and has the ability to use the BodyGuardian remote monitoring system
Exclusion Criteria
- Pregnancy
- Sexually active women of child-bearing potential must have a negative pregnancy test before starting the study on study day 1
- Women who are surgically sterile or those who are postmenopausal for at least 2 years are not considered to be of childbearing potential
- Either have or have bed partners with implanted pacemakers or defibrillators
- Have known skin allergies or sensitivities to acrylic, hydrogel or silicone adhesives
- Have fragile skin
- Are participating in another clinical trial which may impact the results of this study
- Subjects who, in the opinion of investigator, are unable to perform the tasks associated with the protocol
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Paul Friedman, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available