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

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

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.

Study Overview

• Status: Completed
• Conditions: End Stage Renal Disease; End Stage Renal Disease on Dialysis; Dialysis Hypotension; Dialysis Induced Hypertension
• Intervention / Treatment: Device: Intermittent Non-InvasiveBlood Pressure Monitor

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Betty-Jane Sloan, MA, CCRC; Phone Number: 646-317-0701; Email: bjsloan@nyp.org
• Study Contact Backup: Name: Nelson Chen; Phone Number: 646-317-0785; Email: nec9039@nyp.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10019
      • The Rogosin Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Non-Invasive Blood Pressure (NIPB)Monitors; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The Rogosin Institute
• Collaborators: Outset Medical; CareTaker Medical LLC

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2022
• Primary Completion (Actual): February 9, 2024
• Study Completion (Actual): February 9, 2024

Study Registration Dates

• First Submitted: August 10, 2022
• First Submitted That Met QC Criteria: September 13, 2022
• First Posted (Actual): September 14, 2022

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Tablo; Outset Medical, Inc.; Caretaker Medical, LLC; VitalStream; ESKD
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Urologic Diseases; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Kidney Failure, Chronic; Hypotension
• Other Study ID Numbers: 2022-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No