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NCT02609841 · ClinicalTrials.gov registry record
POtassium and Cardiac Rhythm Trends in MaintENance HemoDialysis: A Multicenter, Prospective, Observational Study
A clinical trial, sponsored by ZS Pharma.
- Completed
- Registry status
- 240
- Enrollment target
NCT02609841: Completed study, sponsored by ZS Pharma.
NCT02609841 is a clinical trial that has completed, run by ZS Pharma. The registered enrollment target is 240 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02609841 has completed, sponsored by ZS Pharma.
- COMPLETED
- Registry status
- 240 participants
- Enrollment target
Study 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.
Primary Outcome
Incidence of pre-dialysis hyperkalemia (HK) in patients after the long inter-dialytic period (LIDP) in patients on \<3K dialysate. Hyperkalemia defined as serum potassium (S-K) \>5.0 mEq/L.
Interventions
- DEVICE Cardiac rhythm remote monitoring system
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2015-09-30 |
| Est. Completion | 2016-05-31 |
What the finished NCT02609841 record still lists
NCT02609841 is an observational study that tracks outcomes without assigning an intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Cardiac rhythm remote monitoring system is the first listed.
NCT02609841 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02609841 about?
NCT02609841 is a clinical study titled "POtassium and Cardiac Rhythm Trends in MaintENance HemoDialysis: A Multicenter, Prospective, Observational Study". 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...
What is the current status of trial NCT02609841?
This trial is currently completed. The enrollment target is 240 participants. The study started on 2015-09-30. Estimated completion is 2016-05-31.
What interventions are being tested in trial NCT02609841?
The interventions under investigation include: Cardiac rhythm remote monitoring system (DEVICE).
Who is sponsoring clinical trial NCT02609841?
This trial is sponsored by ZS Pharma, which has 8 total clinical trials registered on ClinicalTrials.gov.
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