Dialysis, Fluid Loss
Conditions
Brief summary
The study is a prospective, single-arm, non-randomized, non-blinded, non-controlled, non-significant risk, single center study enrolling up to 20 subjects consented to undergo a hemodialysis session as a part of their standard prescribed treatment plan. Subjects will consent to undergo non-invasive monitoring with the CM-1500 during three (3) separate sequential hemodialysis sessions.
Interventions
DEVICECM-1500
The CM-1500 is a U.S. FDA cleared non-invasive monitoring device that simultaneously monitors five (5) parameters of a patient's body. A combination of these parameters is represented by a single number known as the Relative Index value. This value is indicative of relative changes in fluid volume.
Sponsors
Zynex Monitoring Solutions
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ability to provide written informed consent * Ability and willingness to comply with the study procedures and duration requirements, including connection of the device to the left wrist/hand and maintaining relatively motionless during the session * 18 years of age or older * Planned to undergo a minimum of three (3) hemodialysis sessions within the two (2) weeks following enrollment.
Exclusion criteria
* Females who are pregnant or breastfeeding * Undergone an amputation of the left upper extremity * Subjects with left arm hemodialysis access only * Diagnosed with dextrocardia * Subjects who have a pacemaker * Subjects who have any other underlying condition that would inhibit completion of participation in the study, per Investigator opinion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Relative Index Value Following a Hemodialysis Procedure | Duration of post-hemodialysis recovery period (10-minutes) | The primary objective is to characterize the average CM-1500 Relative Index (RI) following a hemodialysis procedure. The RI is an investigational value which utilizes proprietary algorithms to combine the changes of multiple measured parameters (utilizing a weighted summation of percent change values) which are indicative of relative changes in fluid volume in adult patients into a single value. The RI is a unitless value with no set minimum or maximum, where 100 is a patient's baseline. Based on the nature of the RI itself, a direct interpretation of a positive or negative outcome cannot be derived from the absolute value, instead it could be used to monitor trending of a patient's parameters relative to their baseline. The average RI after dialysis procedure was calculated by averaging all measured RI values for all subject sessions (3 sessions per subject, totaling 45 sessions) during the 10-min post-hemodialysis recovery period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Intrasubject Variability (Standard Deviation) in Relative Index (RI) During Hemodialysis Sessions | Duration of standard dialysis procedure (Range: 131 to 241 minutes) | The secondary objective is to characterize intrasubject variability in RI changes across 3 hemodialysis sessions. Cohort intrasubject variability was calculated by averaging individual subject standard deviations across enrollments. Variability for each subject is calculated by finding the RI mean and standard deviation for all RI values (1 per sec) during all 3 monitoring sessions. The RI is an investigational value which utilizes proprietary algorithms to combine the changes of multiple measured parameters (utilizing a weighted summation of percent change values) which are indicative of relative changes in fluid volume in adult patients into a single value. The RI is a unitless value with no set min. or max. where 100 is a patient's baseline. Based on the nature of the RI itself, a direct interpretation of a positive or negative outcome cannot be derived from the absolute value, instead it could be used to monitor trending of a patient's parameters relative to their baseline. |
| Mean Intersubject Variability (Standard Deviation) in Relative Index (RI) During Hemodialysis Sessions | Duration of standard dialysis procedure (Range: 131 to 241 minutes) | The secondary objective is to characterize intersubject variability in RI changes across 3 hemodialysis sessions. Intersubject variability was calculated by finding the mean and standard deviation of the variability (standard deviation) from the mean RI values (1 value per sec) for each hemodialysis session monitoring period (3 sessions x 15 subjects = 45 individual monitoring sessions). The RI is an investigational value which utilizes proprietary algorithms to combine the changes of multiple measured parameters (utilizing a weighted summation of percent change values) which are indicative of relative changes in fluid volume in adult patients into a single value. The RI is a unitless value with no set min. or max., where 100 is a patient's baseline. Based on the nature of the RI itself, a direct interpretation of a positive or negative outcome cannot be derived from the absolute value, instead it could be used to monitor trending of a patient's parameters relative to their baseline. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Hemodialysis Single Group Assignment All enrolled subjects will be connected to the CM-1500 for monitoring during their hemodialysis session
CM-1500: The CM-1500 is a U.S. FDA cleared non-invasive monitoring device that simultaneously monitors five (5) parameters of a patient's body. A combination of these parameters is represented by a single number known as the Relative Index value. This value is indicative of relative changes in fluid volume. | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | Hemodialysis Single Group Assignment | — |
|---|---|---|
| Age, Continuous | 52.2 years STANDARD_DEVIATION 16.1 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 15 participants | — |
| Sex: Female, Male Female | 7 Participants | — |
| Sex: Female, Male Male | 8 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 1 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
Primary
Average Relative Index Value Following a Hemodialysis Procedure
The primary objective is to characterize the average CM-1500 Relative Index (RI) following a hemodialysis procedure. The RI is an investigational value which utilizes proprietary algorithms to combine the changes of multiple measured parameters (utilizing a weighted summation of percent change values) which are indicative of relative changes in fluid volume in adult patients into a single value. The RI is a unitless value with no set minimum or maximum, where 100 is a patient's baseline. Based on the nature of the RI itself, a direct interpretation of a positive or negative outcome cannot be derived from the absolute value, instead it could be used to monitor trending of a patient's parameters relative to their baseline. The average RI after dialysis procedure was calculated by averaging all measured RI values for all subject sessions (3 sessions per subject, totaling 45 sessions) during the 10-min post-hemodialysis recovery period.
Time frame: Duration of post-hemodialysis recovery period (10-minutes)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hemodialysis Single Group Assignment | Average Relative Index Value Following a Hemodialysis Procedure | 93.05 Relative Index (RI) | Standard Deviation 0.43 |
Secondary
Mean Intersubject Variability (Standard Deviation) in Relative Index (RI) During Hemodialysis Sessions
The secondary objective is to characterize intersubject variability in RI changes across 3 hemodialysis sessions. Intersubject variability was calculated by finding the mean and standard deviation of the variability (standard deviation) from the mean RI values (1 value per sec) for each hemodialysis session monitoring period (3 sessions x 15 subjects = 45 individual monitoring sessions). The RI is an investigational value which utilizes proprietary algorithms to combine the changes of multiple measured parameters (utilizing a weighted summation of percent change values) which are indicative of relative changes in fluid volume in adult patients into a single value. The RI is a unitless value with no set min. or max., where 100 is a patient's baseline. Based on the nature of the RI itself, a direct interpretation of a positive or negative outcome cannot be derived from the absolute value, instead it could be used to monitor trending of a patient's parameters relative to their baseline.
Time frame: Duration of standard dialysis procedure (Range: 131 to 241 minutes)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hemodialysis Single Group Assignment | Mean Intersubject Variability (Standard Deviation) in Relative Index (RI) During Hemodialysis Sessions | 2.91 Relative Index (RI) | Standard Deviation 3.27 |
Secondary
Mean Intrasubject Variability (Standard Deviation) in Relative Index (RI) During Hemodialysis Sessions
The secondary objective is to characterize intrasubject variability in RI changes across 3 hemodialysis sessions. Cohort intrasubject variability was calculated by averaging individual subject standard deviations across enrollments. Variability for each subject is calculated by finding the RI mean and standard deviation for all RI values (1 per sec) during all 3 monitoring sessions. The RI is an investigational value which utilizes proprietary algorithms to combine the changes of multiple measured parameters (utilizing a weighted summation of percent change values) which are indicative of relative changes in fluid volume in adult patients into a single value. The RI is a unitless value with no set min. or max. where 100 is a patient's baseline. Based on the nature of the RI itself, a direct interpretation of a positive or negative outcome cannot be derived from the absolute value, instead it could be used to monitor trending of a patient's parameters relative to their baseline.
Time frame: Duration of standard dialysis procedure (Range: 131 to 241 minutes)
Population: Each subject was monitored for 3 separate hemodialysis sessions. Intrasubject variability was determined by comparing the 3 sessions for each subject against each other.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hemodialysis Single Group Assignment | Mean Intrasubject Variability (Standard Deviation) in Relative Index (RI) During Hemodialysis Sessions | 2.27 Relative Index (RI) | Standard Deviation 2.07 |