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OpenTrials
Completed

NCT Number: NCT05540457

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

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Key information

Conditions

End Stage Renal Disease Chronic Disease Dialysis Hypotension Dialysis Induced Hypertension Disease Attributes End Stage Renal Disease on Dialysis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Rogosin Institute

New York, 10019, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intermittent Non-InvasiveBlood Pressure Monitor

Device

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 outcomes

  1. Non-invasive Blood Pressure Monitor (NIPB) Measurements

    Time frame: 7 days from start of participation

    Correlation of BP measurements (e.g., systolic, diastolic, mean arterial,and pulse pressures) between NIPB monitors.

Secondary outcomes

  1. Intradialytic Blood Pressure Events

    Time frame: 7 days from start of participation

    Summary of observed intradialytic BP events (hypertensive andhypotensive)

  2. Participant Preference for the Non-invasive Blood Pressure Monitor (NIPB)

    Time frame: 7 days from start of participation

    Participant Preference Questionnaire (PPQ)

Sponsors and collaborators

Lead sponsor

The Rogosin Institute

Other

Collaborators

  • CareTaker Medical LLC
  • Outset Medical

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 14, 2022
Registry last updated
Jun 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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