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NCT05540457 Clinical Trial

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

End Stage Renal Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05540457
Other study ID # 2022-01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 22, 2022
Est. completion date February 9, 2024

Study information
Verified date February 2024
Source The Rogosin Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
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.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Intermittent 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.

Locations
Country Name City State
United States The Rogosin Institute New York New York

Sponsors (3)
Lead Sponsor Collaborator
The Rogosin Institute CareTaker Medical LLC, Outset Medical

Country where clinical trial is conducted

United States, 

Outcome
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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