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Trial Outcomes & Findings for Measuring Thoracic Impedance in Hemodialysis Patients With the u-Cor Monitoring System (NCT NCT03072732)

NCT ID: NCT03072732

Last Updated: 2020-11-04

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

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

Results posted on

2020-11-04

Participant Flow

Patients were recruited at the dialysis clinics of three sites, from November 2016 through February 2017.

Participant milestones

Participant milestones
Measure
Study Arm 1 - Below the Left Axilla
20 patients undergoing hemodialysis, with at least 10 of these patients having congestive heart failure, will have the u-Cor system placed below the left axilla and the ZOE Fluid Status Monitor u-Cor System: Monitoring System ZOE Fluid Status Monitor: Monitoring System
Study Arm 2 - Upper Left Pectoral Area
20 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 u-Cor System: Monitoring System ZOE Fluid Status Monitor: Monitoring System
Overall Study
STARTED
20
20
Overall Study
COMPLETED
20
20
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Study Arm 1 - Below Left Axilla
n=20 Participants
20 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 u-Cor System: Monitoring System ZOE Fluid Status Monitor: Monitoring System
Study Arm 2 - Upper Left Pectoral Area
n=20 Participants
20 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 u-Cor System: Monitoring System ZOE Fluid Status Monitor: Monitoring System
Total
n=40 Participants
Total of all reporting groups
Age, Continuous
58 Years
STANDARD_DEVIATION 9.5 • n=5 Participants
56 Years
STANDARD_DEVIATION 9.5 • n=7 Participants
57 Years
STANDARD_DEVIATION 9.4 • n=5 Participants
Sex: Female, Male
Female
6 Participants
n=5 Participants
4 Participants
n=7 Participants
10 Participants
n=5 Participants
Sex: Female, Male
Male
14 Participants
n=5 Participants
16 Participants
n=7 Participants
30 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants
n=5 Participants
0 Participants
n=7 Participants
2 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
18 Participants
n=5 Participants
20 Participants
n=7 Participants
38 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
3 Participants
n=5 Participants
1 Participants
n=7 Participants
4 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants
n=5 Participants
1 Participants
n=7 Participants
2 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
13 Participants
n=5 Participants
15 Participants
n=7 Participants
28 Participants
n=5 Participants
Race (NIH/OMB)
White
3 Participants
n=5 Participants
3 Participants
n=7 Participants
6 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Region of Enrollment
United States
20 participants
n=5 Participants
20 participants
n=7 Participants
40 participants
n=5 Participants

PRIMARY outcome

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

Population: Adult patients undergoing hemodialysis 3x week, with an expected net fluid removal of at least 2.5 L per dialysis session.

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.

Outcome measures

Outcome measures
Measure
Study Arm 1 - Below Left Axilla
n=20 Participants
20 patients undergoing hemodialysis, with at least 10 of these patients having congestive heart failure, will have the u-Cor system placed below the left axilla and the ZOE Fluid Status Monitor u-Cor System: Monitoring System ZOE Fluid Status Monitor: Monitoring System
Study Arm 2 - Upper Left Pectoral Area
n=20 Participants
20 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 u-Cor System: Monitoring System ZOE Fluid Status Monitor: Monitoring System
Difference in Correlation of Thoracic Impedance With Ultra-filtration Volume (UFV) Between uCor and ZOE
0.66 difference in correlation coefficients
Interval 0.57 to 0.75
0.23 difference in correlation coefficients
Interval 0.12 to 0.35

Adverse Events

Study Arm 1 - Below Left Axilla

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Study Arm 2 - Upper Left Pectoral Area

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Project Manager

ZOLL

Phone: 14127216444

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place