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Clinical Trials/NCT04127877
NCT04127877UnknownNot Applicable

Regional Electric Bio Impedance-assisted Monitoring of Cardiac, Vascular Resistance and Fluid Balance, in Chronic Hemodialysis Patients

Assuta Ashdod Hospital2 sites in 1 country30 target enrollmentStarted: November 18, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
30
Locations
2
Primary Endpoint
Hemodynamic adverse events

Study Overview

Brief Summary

Hemodynamic trends will be assessed using the device, in 100 dialysis sessions in 30 patients, who are prone to develop hypotensive episode during dialysis. Sitting blood pressures will be measured immediately prior to each hemodynamic measurement: before initiation of dialysis, every each hour and in the beginning of hypotension episode, just before the end and 10 min after the end of the treatment.

Gender, age, height, weight, electrode location and blood pressure data will be entered into the device. The device will measure and calculate hemodynamic parameters on each heart beat during 60 s and provides the averaged parameters.

Technology for hemodynamic measurements:

The device (NICaS, NI Medical) is a noninvasive regional bioimpedance cardiac measurement and analysis system (FDA 510k clearance no. K080941, 12 June 2009). The US Food and Drug Administration indication for use of the device states 'NICaS is intended to monitor and display hemodynamic parameters in males and females with known or suspected cardiac disorders needing cardiac assessment'.

SV will be measured by applying an alternating electrical current of 1.4mA at 30 kHz frequency through the patient's body via two pairs of tetrapolar sensors, one pair placed on the wrist of the nonaccess arm above the radial pulse and the other pair on the contralateral ankle above the posterior tibial pulse (Figure 1).

Figure 1 : Sensor location

SV is calculated by Frinerman's formula:

SV¼(dR/R) - q - (L2/Ri) - (ab)/b - KW - HF [2-4], where dR is the impedance change in the arterial system as a result of intraarterial expansion during systole, R is basal resistance, q is blood electrical resistance, L is the patient's height, Ri is basal resistance corrected for gender and age, KWis the correction of weight according to ideal values, HF is a hydration factor that takes into account the ratio between R and body mass index (BMI), which is correlated to body water volume, ab is the electrocardiogram (ECG) R-R wave interval and b is the diastolic time interval. SV is automatically calculated every 20 s and is the average of three measurements obtained consecutively during 60 s of monitoring. The SV index is calculated as SV/body surface area using the Du Bois formula [11]. Heart rate is calculated from a one channel ECG and cardiac (output) index¼SV index - heart rate/1000. Using an oscillometric method, sitting systolic and diastolic blood pressure measurements were made automatically by the dialysis machine. Mean arterial pressure [2 - (diastolicsystolic)/3], cardiac power index [CPI; mean arterial pressure (MAP) -cardiac index - 0.0022 w/m2; normal range 0.45-0.85w/m2] [12, 13] and total peripheral resistance (MAP/ cardiac index - 80 dyn - s/cm5 - m2; normal range 1600-3000 dyn - s/cm5- m2) [13] will be calculated.

As the device measures pulsatile flow and is blinded to constant flow, fluid removal during dialysis has no impact on measurement accuracy. This was recently validated by correlating SV to ECG measurements during hemodialysis treatments. Good correlation was maintained during treatment. Further, NICaS performance immunity to fluid reduction was demonstrated by the maintenance of correlation to ECG results throughout dialysis treatments [9]. The results are drawn on hemodynamic graphs showing the MAP (y-axis) as a function of cardiac index (x-axis); curves of total peripheral resistance index (TPRI) and CPI are displayed. Ranges for the normal population are depicted by a dotted octagon.

Detailed Description

Hemodynamic trends will be assessed using the device, in 100 dialysis sessions in 30 patients, who are prone to develop hypotensive episode during dialysis. Sitting blood pressures will be measured immediately prior to each hemodynamic measurement: before initiation of dialysis, every each hour and in the beginning of hypotension episode, just before the end and 10 min after the end of the treatment.

Gender, age, height, weight, electrode location and blood pressure data will be entered into the device. The device will measure and calculate hemodynamic parameters on each heart beat during 60 s and provides the averaged parameters.

Technology for hemodynamic measurements:

The device (NICaS, NI Medical) is a noninvasive regional bioimpedance cardiac measurement and analysis system (FDA 510k clearance no. K080941, 12 June 2009). The US Food and Drug Administration indication for use of the device states 'NICaS is intended to monitor and display hemodynamic parameters in males and females with known or suspected cardiac disorders needing cardiac assessment'.

SV will be measured by applying an alternating electrical current of 1.4mA at 30 kHz frequency through the patient's body via two pairs of tetrapolar sensors, one pair placed on the wrist of the nonaccess arm above the radial pulse and the other pair on the contralateral ankle above the posterior tibial pulse (Figure 1).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Chronic hemodialysis patients

Exclusion Criteria

  • Age limits

Arms & Interventions

CHRONIC HEMODIALYSIS PATIENTS, NICAS-ASSISTED MONITORING

Experimental

Chronic hemodialysis patients, NICAS-assisted monitored

Intervention: NICAS (Device)

Control hemodialysis patients

No Intervention

Chronic hemodialysis patients, conventional clinical care and monitoring.

Outcomes

Primary Outcomes

Hemodynamic adverse events

Time Frame: One year

Extreme blood pressure decrease, hospitalization, death

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Assuta Ashdod Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Adi Leiba

Proffesor Adi Leiba, head, Nephrology and Hypertension Institute,

Assuta Ashdod Hospital

Study Sites (2)

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