CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 240 enrolled
Drug / intervention
Cardiac rhythm remote monitoring systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02609841
NCT02609841N/ACompleted
CompareCT.gov

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

ZS Pharma, Inc.·observational·Posted Nov 20, 2015·Updated Jul 25, 2017

In Brief

An observational study evaluating Cardiac rhythm remote monitoring system for Hyperkalemia. Completed, enrolled 240 participants across 9 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsHyperkalemia
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 20, 2015
Enrollment StartSep 30, 2015
Primary CompletionMay 31, 2016
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 10.6 years ago

Interventions

Cardiac rhythm remote monitoring systemdevice

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