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

NCT02609841 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 240

Last updated 2017-07-25

Study results available
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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.

Conditions

  • Hyperkalemia

Interventions

DEVICE

Cardiac rhythm remote monitoring system

Non-invasive wearable remote cardiac rhythm monitoring system used throughout 12 days of study.

Sponsors & Collaborators

  • ZS Pharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Henrik Rasmussen, MD, PhD · ZS Pharma, Inc.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2016-05-31
Completion
2016-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02609841 on ClinicalTrials.gov