CompletedNot Applicable

Measuring Thoracic Impedance in Hemodialysis Patients With the u-Cor Monitoring System

United States40 participantsStarted 2016-11-03

Plain-language 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.

Who can participate

Age range21 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

What they're measuring

Difference in Correlation of Thoracic Impedance With Ultra-filtration Volume (UFV) Between uCor and ZOE

Timeframe: 15 minutes prior the start of one hemodialysis session to 15 minutes post completion of one hemodialysis session, approximately 2 to 6 hours.

Trial details

NCT IDNCT03072732

SponsorZoll Medical Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-02-01

Results submitted2020-09-04