Bio Impedance-assisted Monitoring of Chronic Hemodialysis Patients

NCT04127877 | Unknown DMC

• 1 other identifier: 0069-18
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Diseases; Hemodialysis Complication

Outcome Measures

Primary Outcomes (1)

• Hemodynamic adverse events

  Extreme blood pressure decrease, hospitalization, death

  One year

Study Arms (2)

CHRONIC HEMODIALYSIS PATIENTS, NICAS-ASSISTED MONITORING

EXPERIMENTAL

Chronic hemodialysis patients, NICAS-assisted monitored

Device: NICAS

Control hemodialysis patients

NO INTERVENTION

Chronic hemodialysis patients, conventional clinical care and monitoring.

Interventions

NICAS DEVICE

Electric regional bio impedance device

CHRONIC HEMODIALYSIS PATIENTS, NICAS-ASSISTED MONITORING

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic hemodialysis patients

You may not qualify if:

• Age limits

Sponsors & Collaborators

• Assuta Ashdod Hospital: lead

Study Sites (1)

Nephrology and Hypertention Institute, hemodialysis unit

Ashdod, 7747629, Israel

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Adi Leiba, Prof

  ASSUTA HOSPITAL ASHDOD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ze'ev Katzir, MD

CONTACT

972052 6300563; zeevk@assuta.co.il

Batel Ohayon, BSc

CONTACT

972 0723398269; bateloh@assuta.co.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Proffesor Adi Leiba, head, Nephrology and Hypertension Institute,

Model Details: Randomized Controlled study

Study Record Dates

• First Submitted: October 13, 2019
• First Posted: October 16, 2019
• Study Start: November 18, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2020
• Last Updated: October 16, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)