Clinical Trials Logo
  1. Home
  2. End Stage Renal Disease
  3. NCT05540457
  4. Details
NCT05540457 Clinical Trial

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
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design

Related Conditions & MeSH terms

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
See also
  Status Clinical Trial Phase
Completed NCT04076488 - Feasibility of an Interactive Tablet-based Exercise Program for People With Chronical Diseases N/A
Completed NCT03289650 - Extended Release Tacrolimus vs. Twice-Daily Tacrolimus Phase 3
Completed NCT04042324 - A Study to Investigate the Effect of Triferic Plus Heparin Infusion Compared to Heparin Alone on Coagulation Parameters in Hemodialysis Patients Phase 1/Phase 2
Completed NCT01242904 - Use of a Bimodal Solution for Peritoneal Dialysis Phase 2
Active, not recruiting NCT03183245 - Comparison of the Human Acellular Vessel (HAV) With Fistulas as Conduits for Hemodialysis Phase 3
Completed NCT03257410 - Theranova 400 Dialyzer In End Stage Renal Disease (ESRD) Patients N/A
Completed NCT03627299 - Renal Transplants in Hepatitis C Negative Recipients With Nucleic Acid Positive Donors Phase 4
Recruiting NCT05917795 - Endoscopic Sleeve Gastroplasty With Endomina® for the Treatment of Obesity in Kidney Transplant Candidates N/A
Terminated NCT03539861 - Immunomodulatory Biomimetic Device to Treat Myocardial Stunning in End-stage Renal Disease Patients N/A
Withdrawn NCT02130817 - Belatacept in Kidney Transplantation of Moderately Sensitized Patients Phase 4
Not yet recruiting NCT04900610 - The Effect of Vitamin K2 Supplementation on Arterial Stifness and Cardiovascular Events in PEritonial DIAlysis N/A
Recruiting NCT02176434 - Pilot Feasibility Study of Combined Kidney and Hematopoietic Stem Cell Transplantation to Cure End-stage Renal Disease N/A
Active, not recruiting NCT02581449 - Effect of Omega-3 Fatty Acids on Oxidative Stress and Dyslipidemia in Pediatric Patients Undergoing Hemodialysis Phase 2
Completed NCT02832440 - Comparison of Two Exercise Programmes in Patients Undergoing Hemodialysis N/A
Completed NCT02134314 - C1INH Inhibitor Preoperative and Post Kidney Transplant to Prevent DGF & IRI Phase 1/Phase 2
Completed NCT02830490 - Reliability of Functional Measures in Hemodialysis Patient. N/A
Completed NCT02832466 - Quantifying the Deterioration of Physical Function in Renal Patients N/A
Completed NCT02215655 - Increasing Autonomous Motivation in ESRD to Enhance Phosphate Binder Adherence N/A
Recruiting NCT01912001 - Virtual Ward for Home Dialysis N/A
Completed NCT01951404 - Does ALlopurinol Regress lefT Ventricular Hypertrophy in End Stage REnal Disease: The ALTERED Study Phase 4