Evaluation of Non-Invasive Continuous vs Intermittent BloodPressure Monitors in Maintenance Dialy… (NCT05540457) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Non-Invasive Continuous vs Intermittent BloodPressure Monitors in Maintenance Dialysis (BP Dialysis)
United States10 participantsStarted 2022-09-22
Plain-language summary
Prospective, single center, open label, non-randomized, post-market study of the Tablo Hemodialysis System and VitalStream Monitor in participants with End-Stage KidneyDisease undergoing In-Center Hemodialysis.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participant is at least 18 years of age and has provided informed consent and has signed a Health Insurance Portability and Accountability Act of 1996 (HIPAA) compliant authorization statement.
* Participant weighs ≥ 34kg.
* Participant has end stage kidney disease (ESKD) adequately treated by maintenance dialysis.
Exclusion Criteria:
* Participant has lack of perfusion of the digitalarteries and arterioles in the lower arm and hand.
* The Non-Invasive Blood Pressure (NIPB) monitorcuffs (finger and/or brachial) are unable to becorrectly sized to the participant.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is already completed, is the data published or available yet, and could the results about continuous versus intermittent blood pressure monitoring change how my blood pressure is being managed during my dialysis sessions?
2I sometimes experience low or high blood pressure during dialysis — based on what this study found about non-invasive continuous monitoring, is that type of monitor something my dialysis center could use for me?
3How does the blood pressure monitoring method currently used at my dialysis center compare to what was tested in this trial, and do you think continuous monitoring would give a more accurate picture of what's happening to my blood pressure during treatment?
4Given that this trial specifically looked at dialysis-induced hypotension and hypertension, could the findings help explain why I have blood pressure swings during my sessions, and are there any changes to my care we should consider based on this research?
5Are there any follow-up studies or changes in standard practice coming out of this completed trial that I should be aware of as someone on maintenance dialysis?'}
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.