N/A
N=240
POtassium and Cardiac Rhythm Trends in MaintENance HemoDialysis: A Multicenter, Prospective, Observational Study
Hyperkalemia
Bottom Line
View on ClinicalTrials.gov: NCT02609841 ↗Enrolled (actual)
240
Serious AEs
—
Results posted
Jun 2017
Primary outcome: Primary: Incidence of Pre-dialysis HK After the LIDP in <3K Dialysate Patients — 50; 37 Percent of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Cardiac rhythm remote monitoring system (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- ZS Pharma, Inc.
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Pre-dialysis HK After the LIDP in <3K Dialysate Patients |
50; 37 | — |
| SECONDARY Incidence of Pre-dialysis Hyperkalemia (HK) After the Long Inter-dialytic Period (LIDP) in Patients on ≥3K Dialysate. |
36; 21 | — |
| SECONDARY Incidence of Cardiac Arrhythmias |
51; 16 | — |
Summary
This study assesses 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. Dialysate K (relative potassium concentration in dialysate) must be stable for 2 weeks prior to enrollment.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.
Eligibility Criteria
Inclusion Criteria
- Provision of written informed consent.
- 18 years of age or older.
- Subject has ESRD 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 a childbearing potential.
- Subjects or bed partners with implanted pacemakers or defibrillators.
- Known skin allergies or sensitivities to acrylic, hydrogel or silicone adhesives.
- Fragile skin.
- Participation 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.
Data sourced from ClinicalTrials.gov (NCT02609841). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.