Dialysis Hypotension, Dialysis Induced Hypertension, End Stage Renal Disease, End Stage Renal Disease on Dialysis
Conditions
Keywords
Tablo, Outset Medical, Inc., Caretaker Medical, LLC, VitalStream, ESKD
Brief 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.
Interventions
DEVICEIntermittent Non-InvasiveBlood Pressure Monitor
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.
Sponsors
Outset Medical
CareTaker Medical LLC
The Rogosin Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Non-invasive Blood Pressure Monitor (NIPB) Measurements | 7 days from start of participation | Correlation of BP measurements (e.g., systolic, diastolic, mean arterial,and pulse pressures) between NIPB monitors. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intradialytic Blood Pressure Events | 7 days from start of participation | Summary of observed intradialytic BP events (hypertensive andhypotensive) |
| Participant Preference for the Non-invasive Blood Pressure Monitor (NIPB) | 7 days from start of participation | Participant Preference Questionnaire (PPQ) |
Countries
United States
Outcome results
None listed