Neck-Worn Monitoring Sensor for - A Study for Monitoring Subjects With Fluid-Management Issues During Dialysis

NCT02140905 | Completed

• 1 other identifier: PERM-IRB-0001
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

The study has two objectives based on the intended-use measurements and populations described above. The first objective is to show that relative changes in impedance as measured by the test device (ΔSFI) are strongly correlated with the amount of fluid removed during dialysis (ΔF) for subjects with ESRD and possibly Heart Failure. The second objective is to demonstrate correlation between ΔSFI and relative changes in impedance (ΔZ) as measured by the reference device.

Conditions

Heart Failure; Kidney Disease

Keywords

Hemodialysis; Heart failure; Impedance; Fluids

Outcome Measures

Primary Outcomes (1)

• Comparison of fluid measurement made with the Neck-Worn Monitoring System and those with an FDA approved fluid measurement device. Both measurements will be compared to the actual fluids removed during one dialysis session.

  The study's primary objective is to determine the effectiveness of SFI measurements made by the Neck-Worn Monitoring System for characterizing fluid levels compared to an FDA approved device. Data collected includes SFI from the Neck-Worn Monitoring System and a reference device, fluid extracted during a dialysis session. Data will be collected every 15 minutes.

  Measurements will be collected during one dialysis session. Each Session will last between 2 and 5.5 hours. All measurements will be completed within one month.

Study Arms (1)

Patients undergoing hemodialysis.

Subjects participating in the study

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be volunteers, solicited using accepted recruitment methods, such as through clinicians associated with dialysis centers. Subjects will have a clinical diagnosis of Kidney Failure and will be currently undergoing Hemodialysis with possible related co-morbidity of Heart Failure.

You may qualify if:

• Subject is between 21 (twenty-one) and 90 (ninety) years of age at screening.
• Subject will have one or more of the following clinical diagnoses related to fluid-management issues: ESRD, Heart Failure.
• Subject and/or legally authorized person/representative is willing to undergo the Informed Consent process prior to enrollment in the study.
• Subject is a candidate for this study based on the PI's opinion and knowledge of the subject's condition.

You may not qualify if:

• Subject is participating in another clinical study that may affect the results of either study.
• Subject is unable or not willing to wear electrode patches as required.
• Subject has skin sensitivity to adhesive or hydrogel materials used in electrode patches.
• Subject has a pacemaker, implanted cardioverter-defibrillator, or ventricular assist device.
• Subject is considered by the PI to be medically unsuitable for study participation

Sponsors & Collaborators

• Baxter Healthcare Corporation: lead

Study Sites (1)

Dialysis Center, Inc.

North Brunswick, New Jersey, 08902, United States

Location

MeSH Terms

Conditions

Heart Failure; Kidney Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Matthew Banet, PhD

  Baxter Healthcare Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2014
• First Posted: May 16, 2014
• Study Start: April 1, 2014
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: May 20, 2014

Record last verified: 2014-05

Locations

US (1)