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

Not Applicable

Completed

• Conditions: Dialysis Hypotension; End Stage Renal Disease; End Stage Renal Disease on Dialysis; Dialysis Induced Hypertension
• Interventions: Device: Intermittent Non-InvasiveBlood Pressure Monitor

• Registration Number: NCT05540457
• Lead Sponsor: The Rogosin Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-10
• Study First Submitted QC: 2022-09-13
• Study First Posted: 2022-09-14
• Study Start: 2022-09-22
• Primary Completion: 2024-02-09
• Study Completion: 2024-02-09
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-08
• Last Update Posted: 2025-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Non-Invasive Blood Pressure (NIPB)Monitors	Intermittent Non-InvasiveBlood Pressure Monitor	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Participant Preference for the Non-invasive Blood Pressure Monitor (NIPB)	7 days from start of participation	Participant Preference Questionnaire (PPQ)
Intradialytic Blood Pressure Events	7 days from start of participation	Summary of observed intradialytic BP events (hypertensive andhypotensive)

Trial Locations

Locations (1)

The Rogosin Institute; 🇺🇸 New York, New York, United States