POtassium and Cardiac Rhythm Trends in MaintENance HemoDialysis: A Multicenter, Prospective, Observational Study

Overview

  • Study type

    Observational
  • Study IDs

  • Describes 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.
  • 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. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

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 us for help.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Paul Friedman, M.D.

Closed for enrollment

Additional contact information

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Phone: 800-664-4542 (toll-free)

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