End Stage Renal Disease Clinical Trial
Official title:
Evaluation of Non-Invasive Continuous vs Intermittent BloodPressure Monitors in Maintenance Dialysis
Verified date | February 2024 |
Source | The Rogosin Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | February 9, 2024 |
Est. primary completion date | February 9, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | The Rogosin Institute | New York | New York |
Lead Sponsor | Collaborator |
---|---|
The Rogosin Institute | CareTaker Medical LLC, Outset Medical |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Intradialytic Blood Pressure Events | Summary of observed intradialytic BP events (hypertensive andhypotensive) | 7 days from start of participation | |
Secondary | Participant Preference for the Non-invasive Blood Pressure Monitor (NIPB) | Participant Preference Questionnaire (PPQ) | 7 days from start of participation |
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