Evaluation of Non-Invasive Continuous vs Intermittent BloodPressure Monitors in Maintenance Dialysis (BP Dialysis)

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Non-Invasive Continuous vs Intermittent BloodPressure Monitors in Maintenance Dialysis

Conditions
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End Stage Renal Disease, End Stage Renal Disease on Dialysis, Dialysis Hypotension, Dialysis Induced Hypertension

Intervention / Treatment
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* Device: Intermittent Non-InvasiveBlood Pressure Monitor


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Non-Invasive Blood Pressure (NIPB)Monitors<br>NIPB Tablo Brachial Cuff (Intermittent): Will be placed contralateral to the access arm. Blood pressure measurements will be collected pre-dialysis, every 30minutes during dialysis, and post-dialysis. VitalStream Monitor (Continuous):A cuff will be applied to the middlefinger ipsilateral to the accessarm. Blood pressuremeasurements will be collectedpre-dialysis, continuously duringdialysis, and post-dialysis. | Device: Intermittent Non-InvasiveBlood Pressure Monitor<br>* Brachial cuff integrated with theTablo Hemodialysis System. Cuffwill be placed contralateral to theaccess arm, with measurementscollected pre-dialysis, every 30minutes during dialysis, and post-dialysis. Device: Continuous Non-InvasiveBlood Pressure Monitor VitalStream Monitor. Finger cuffwill be placed ipsilateral to theaccess arm, with measurementscollected pre-dialysis,continuously during dialysis, andpost-dialysis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-invasive Blood Pressure Monitor (NIPB) Measurements | Correlation of BP measurements (e.g., systolic, diastolic, mean arterial,and pulse pressures) between NIPB monitors. | 7 days from start of participation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intradialytic Blood Pressure Events | Summary of observed intradialytic BP events (hypertensive andhypotensive) | 7 days from start of participation | 
| Participant Preference for the Non-invasive Blood Pressure Monitor (NIPB) | Participant Preference Questionnaire (PPQ) | 7 days from start of participation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tablo, Outset Medical, Inc., Caretaker Medical, LLC, VitalStream, ESKD