N/A
Completed N=240
POtassium and Cardiac Rhythm Trends in MaintENance HemoDialysis: A Multicenter, Prospective, Observational Study
Source: ClinicalTrials.gov NCT02609841 ↗Enrolled (actual)
240
Serious AEs
—
Results posted
Jun 2017
Primary outcomePrimary: Incidence of Pre-dialysis HK After the LIDP in <3K Dialysate Patients — 50; 37 Percent of participants
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.
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 | — |
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. Informational only — not medical advice.