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

Primary Purpose

End Stage Renal Disease, End Stage Renal Disease on Dialysis, Dialysis Hypotension

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intermittent Non-InvasiveBlood Pressure Monitor
Sponsored by
The Rogosin Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for End Stage Renal Disease focused on measuring Tablo, Outset Medical, Inc., Caretaker Medical, LLC, VitalStream, ESKD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Rogosin InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Non-Invasive Blood Pressure (NIPB)Monitors

Arm Description

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.

Outcomes

Primary Outcome Measures

Non-invasive Blood Pressure Monitor (NIPB) Measurements
Correlation of BP measurements (e.g., systolic, diastolic, mean arterial,and pulse pressures) between NIPB monitors.

Secondary Outcome Measures

Intradialytic Blood Pressure Events
Summary of observed intradialytic BP events (hypertensive andhypotensive)
Participant Preference for the Non-invasive Blood Pressure Monitor (NIPB)
Participant Preference Questionnaire (PPQ)

Full Information

First Posted
August 10, 2022
Last Updated
October 17, 2023
Sponsor
The Rogosin Institute
Collaborators
Outset Medical, CareTaker Medical LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05540457
Brief Title
Evaluation of Non-Invasive Continuous vs Intermittent BloodPressure Monitors in Maintenance Dialysis (BP Dialysis)
Official Title
Evaluation of Non-Invasive Continuous vs Intermittent BloodPressure Monitors in Maintenance Dialysis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 22, 2022 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Rogosin Institute
Collaborators
Outset Medical, CareTaker Medical LLC

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease, End Stage Renal Disease on Dialysis, Dialysis Hypotension, Dialysis Induced Hypertension
Keywords
Tablo, Outset Medical, Inc., Caretaker Medical, LLC, VitalStream, ESKD

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Non-Invasive Blood Pressure (NIPB)Monitors
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Intermittent Non-InvasiveBlood Pressure Monitor
Intervention Description
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.
Primary Outcome Measure Information:
Title
Non-invasive Blood Pressure Monitor (NIPB) Measurements
Description
Correlation of BP measurements (e.g., systolic, diastolic, mean arterial,and pulse pressures) between NIPB monitors.
Time Frame
7 days from start of participation
Secondary Outcome Measure Information:
Title
Intradialytic Blood Pressure Events
Description
Summary of observed intradialytic BP events (hypertensive andhypotensive)
Time Frame
7 days from start of participation
Title
Participant Preference for the Non-invasive Blood Pressure Monitor (NIPB)
Description
Participant Preference Questionnaire (PPQ)
Time Frame
7 days from start of participation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Betty-Jane Sloan, MA, CCRC
Phone
646-317-0701
Email
bjsloan@nyp.org
First Name & Middle Initial & Last Name or Official Title & Degree
Nelson Chen
Phone
646-317-0785
Email
nec9039@nyp.org
Facility Information:
Facility Name
The Rogosin Institute
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Betty-Jane Sloan, MA, CCRC
Phone
646-317-0701
Email
bjsloan@nyp.org
First Name & Middle Initial & Last Name & Degree
Frank Liu, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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