Measuring Thoracic Impedance in Hemodialysis Patients With the u-Cor Monitoring System
MaTcH
1 other identifier
interventional
40
1 country
3
Brief Summary
The purpose of this study is to measure the fluid changes in the body using a device called the µ-Cor System, an investigational device. The µ-Cor System will record the fluid changes in the body, as well as ECG (electrocardiogram or an electrical tracing of your heart rhythm) heart rate, breathing rate, posture and activity at regular intervals. The information collected by the µ-Cor System will then be compared to the actual fluid removed through dialysis and to the information collected by an FDA (Food and Drug Administration) cleared device called ZOE (NonInvasive Medical Technologies), a monitor which also measures the fluid changes in the body. The objectives of this study are to document any differences in measurement of thoracic impedance obtained from the µ-Cor System and the ZOE system. Thoracic impedance is a measure of the electrical activity in the chest that varies with changes in body size and composition, fluid volume, breathing status and other variables. Measurements of the amount of fluid removed during dialysis will also be compared between the µ-Cor System, the ZOE system and the actual fluid removed. The ability of the µ-Cor System to measure thoracic impedance will be tested by placing the device randomly at one of two locations:
- Study Arm 1: side location- below left axilla
- Study Arm 2: front location - upper left pectoral area Both the µ-Cor System and the ZOE System will be worn simultaneously during one dialysis session. The ZOE system device is placed on the chest- 2 points: 1 at the base of your neck and 1 in your mid chest.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2016
Shorter than P25 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 3, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedFirst Submitted
Initial submission to the registry
March 1, 2017
CompletedFirst Posted
Study publicly available on registry
March 7, 2017
CompletedResults Posted
Study results publicly available
November 4, 2020
CompletedNovember 4, 2020
October 1, 2020
3 months
March 1, 2017
September 4, 2020
October 9, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Difference in Correlation of Thoracic Impedance With Ultra-filtration Volume (UFV) Between uCor and ZOE
The primary endpoint measurement is the difference of 1) the Pearson correlation of thoracic impedance made by the u-Cor System to UFV and 2) the Pearson correlation of thoracic impedance made by the ZOE to UFV. Differences in correlation coefficients were calculated for each subject and each study arm.
15 minutes prior the start of one hemodialysis session to 15 minutes post completion of one hemodialysis session, approximately 2 to 6 hours.
Study Arms (2)
study arm 1 - below left axilla
OTHER20 patients undergoing hemodialysis, with at least 10 of these patients having congestive heart failure, will have the u-Cor system placed below left axilla and the ZOE Fluid Status Monitor
study arm 2-upper left pectoral area
OTHER20 patients undergoing hemodialysis, with at least 10 of these patients having congestive heart failure, will have the u-Cor system placed on the upper left pectoral area and the ZOE Fluid Status Monitor
Interventions
Monitoring System
Monitoring System
Eligibility Criteria
You may qualify if:
- Men and women at least 21 years of age.
- Is currently scheduled to undergo hemodialysis 3 times per week in a clinic setting and has been on this regimen for at least 3 months.
- For those patients with CHF: were diagnosed with CHF by a qualified provider and show symptomatic signs of New York Heart Association (NYHA) Class II to IV at enrollment.
- Is prescribed a net fluid removal of at least 2.5 L during the hemodialysis session.
- Is willing and able to sign informed consent in English.
You may not qualify if:
- Is a female patient with a known pregnancy or is unsure of pregnancy status.
- Has known allergies or skin sensitivities to electrode hydrogel and/or acrylic based adhesive.
- Has skin breakdown in areas where device and electrode placement is required.
- Was hospitalized within the 2 weeks prior to enrollment.
- Had intradialytic hypotension requiring administration of intravenous (IV) fluids of ≥250 mL or that resulted in a referral to urgent care, within 2 weeks prior to enrollment.
- Had myocardial infarction, acute coronary syndrome, or stroke within 4 weeks prior to enrollment.
- Has active nephrotic syndrome
- Has severe malnutrition, as diagnosed per a qualified provider.
- Is participating in another clinical trial.
- Has an implanted device that might interfere with the µ-Cor.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
DaVita Clinical Research
Lakewood, Colorado, 80228, United States
Orlando Clinical Research Center
Orlando, Florida, 32809, United States
DaVita Clinical Research
Minneapolis, Minnesota, 55404, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Project Manager
- Organization
- ZOLL
Study Officials
- STUDY DIRECTOR
Madhuri Bhat, MS
Zoll Medical Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 1, 2017
First Posted
March 7, 2017
Study Start
November 3, 2016
Primary Completion
February 1, 2017
Study Completion
February 1, 2017
Last Updated
November 4, 2020
Results First Posted
November 4, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share