POtassium and Cardiac Rhythm Trends in MaintENance HemoDialysis: A Multicenter, Prospective, Observational Study (PORTEND)
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|ClinicalTrials.gov Identifier: NCT02609841|
Recruitment Status : Completed
First Posted : November 20, 2015
Results First Posted : June 23, 2017
Last Update Posted : July 25, 2017
|Condition or disease||Intervention/treatment|
|Hyperkalemia||Device: Cardiac rhythm remote monitoring system|
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. Approximately 240 Subjects who meet the eligibility criteria and sign the informed consent form can be enrolled in the study, after which a subject number will be assigned. 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. Baseline data will be collected including subject demographics, dialysis prescription, and symptom assessment. In addition, results of clinical laboratory tests and urea reduction ratio (URR), dialyzer clearance-time-volume of distribution of urea (Kt/V), and intact parathyroid hormone (PTH) obtained within the 4 weeks prior to the first dialysis treatment on Study Day 1 will be collected from regular monthly labs to establish baseline.
Subjects will be assessed in the dialysis clinic/research center over a period of 12 days. Subjects will start the study on the first day of a given week's dialysis regimen (ie, Monday or Tuesday). Subjects who are on a Monday, Wednesday, and Friday dialysis schedule will skip the Saturday visit, and subjects who are on a Tuesday, Thursday, and Saturday dialysis schedule will skip the Sunday visit during the 12-day study duration.
Subjects will undergo blood collection at each visit, including 6 dialysis days and 5 inter-dialysis days. On dialysis days, blood samples will be collected immediately before and at the end of dialysis treatment. During the dialysis treatments on Study Days 1 and 3 only, additional blood samples will be obtained at 30 minutes and 1 hour (± 15 minutes) after the start of dialysis for chemistry. On inter-dialysis days, the dialysis clinic/research center will make an effort to collect blood samples at the same approximate time that dialysis treatment would have started on days of dialysis. Otherwise, samples may be collected when the subject is able to visit the dialysis clinic/research center.
Vital signs including heart rate and blood pressure, and body weight will be collected at each visit. On dialysis days, both pre- and post-dialysis weights will be collected, along with vital signs obtained during dialysis. A specifically designed symptom assessment will also be performed at specified times throughout the study.
The subjects will also undergo cardiac rhythm monitoring using a non-invasive, Food and Drug Administration cleared, wearable device (BodyGuardian® remote monitoring system) throughout the 12 days of participation in the study. This will be used to assess for cardiac arrhythmias, as well as to correlate S-K levels with signal-averaged, processed ECG.
|Study Type :||Observational|
|Actual Enrollment :||240 participants|
|Official Title:||POtassium and Cardiac Rhythm Trends in MaintENance HemoDialysis (PORTEND): A Multicenter, Prospective, Observational Study|
|Actual Study Start Date :||September 30, 2015|
|Actual Primary Completion Date :||May 31, 2016|
|Actual Study Completion Date :||May 31, 2016|
Cardiac rhythm remote monitoring system
Subjects use non-invasive wearable BodyGuardian remote monitoring system throughout 12 days of study.
Device: Cardiac rhythm remote monitoring system
Non-invasive wearable remote cardiac rhythm monitoring system used throughout 12 days of study.
Other Name: BodyGuardian
- Incidence of Pre-dialysis HK After the LIDP in <3K Dialysate Patients [ Time Frame: 12 Days ]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.
- Incidence of Pre-dialysis Hyperkalemia (HK) After the Long Inter-dialytic Period (LIDP) in Patients on ≥3K Dialysate. [ Time Frame: 12 days ]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.
- Incidence of Cardiac Arrhythmias [ Time Frame: 12 days ]Incidence of serious cardiac arrhythmias in patients during the observational period. Serious arrhythmias defined as ventricular tachycardia or > 5 sec pause.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02609841
|United States, California|
|Los Angeles, California, United States, 90022|
|San Jose, California, United States, 95128|
|United States, Colorado|
|Denver, Colorado, United States, 80230|
|United States, Illinois|
|Evergreen Park, Illinois, United States, 60805|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|United States, New York|
|Flushing, New York, United States, 11355|
|United States, Tennessee|
|Chattanooga, Tennessee, United States, 37408|
|United States, Texas|
|Lufkin, Texas, United States, 75904|
|San Antonio, Texas, United States, 78215|
|Study Chair:||Henrik Rasmussen, MD, PhD||ZS Pharma, Inc.|