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

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=99 Participants	56 Years STANDARD_DEVIATION 9.5 • n=107 Participants	57 Years STANDARD_DEVIATION 9.4 • n=206 Participants
Sex: Female, Male Female	6 Participants n=99 Participants	4 Participants n=107 Participants	10 Participants n=206 Participants
Sex: Female, Male Male	14 Participants n=99 Participants	16 Participants n=107 Participants	30 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=99 Participants	0 Participants n=107 Participants	2 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=99 Participants	20 Participants n=107 Participants	38 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=99 Participants	1 Participants n=107 Participants	4 Participants n=206 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants
Race (NIH/OMB) Black or African American	13 Participants n=99 Participants	15 Participants n=107 Participants	28 Participants n=206 Participants
Race (NIH/OMB) White	3 Participants n=99 Participants	3 Participants n=107 Participants	6 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Region of Enrollment United States	20 participants n=99 Participants	20 participants n=107 Participants	40 participants n=206 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.

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

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place