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
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Dialysis Hypotension
• End Stage Renal Disease
• End Stage Renal Disease on Dialysis
• Hypotension
• Kidney Diseases
• Kidney Failure, Chronic

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