Evaluation of Fluid Resuscitation in Shocked Patients by Electrical Cardiometry in Comparison to Transthoracic Echocardiography.

Study Overview
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Brief Summary
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The aim of this study is to evaluate the diagnostic accuracy of electrical cardiometry (EC) for the noninvasive determination of fluid responsiveness in critically ill shocked patients and agreement of EC compared to transthoracic echocardiography (TTE)

Detailed Description
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Electrical cardiometry (EC), based on thoracic electrical bioimpedance, can measure SV continuously and non-invasively. The ECs working principle of estimation of SV is to utilize changes in thoracic electrical impedance, which is mainly influenced by erythrocyte orientation and peak flow velocity in the ascending aorta throughout the cardiac cycle. Electrical cardiometry (EC) has been validated to monitor SV and other hemodynamic parameters non-invasively compared to different techniques such as thermodilution technique, transesophageal Doppler echocardiography and cardiac catheterization including critically ill patients, intra-operative settings, in pregnant women, in children with congenital heart diseases, even in obese children

Official Title
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Evaluation of Fluid Resuscitation in Shocked Patients by Electrical Cardiometry in Comparison to Transthoracic Echocardiography

Conditions
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Fluid Resuscitation, Electrical Cardiometry, Transthoracic Echocardiography, Shock

Intervention / Treatment
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* Device: Assessment of fluid responsiveness by electrical cardiometry


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age from 25 to 65 years old. Both sexes. Patients with clinical criteria of shock [mean arterial pressure (MAP) ≤ 65 mmHg and tissue hypoperfusion (ScvO2 <70%, P(cv-a) CO2 ≥6 mmHg, CRT ≥4 s and lactate >2mmol/l). Exclusion Criteria: Refusal to sign the consent by a first degree relative. Previous cardiac disease, rhythm other than sinus rhythm or heart rate > 140 beat/min. Renal failure (acute or chronic).

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Fluid responder<br>All patients will undergo a volume expansion test or fluid challenge according to standard protocol. The volume expansion test will be performed with an intravenous infusion of 0.9% sodium chloride (500mL) within 15 minutes. The patient becomes a fluid responder if SV increases by > 10% after the fluid challenge. | Device: Assessment of fluid responsiveness by electrical cardiometry<br>* Electrical cardiometry (EC) measurements: by the ICON_ hemodynamic monitor (ICON Cardiotropic, Inc., La Jolla, CA 92307; Osyka Medical GmbH, Berlin, and Germany, model C3). Transthoracic echocardiography (TTE) measurements will be performed equipped with echo probe. SV of the left ventricle will be calculated using LVOT diameter (D) just below the aortic valve from parasternal long-axis view and VTI measured in LVOT from apical 5 chamber view (by pulsed wave Doppler).<br>|
| Fluid non-responder<br>All patients will undergo a volume expansion test or fluid challenge according to standard protocol. The volume expansion test will be performed with an intravenous infusion of 0.9% sodium chloride (500mL) within 15 minutes. The patient becomes a fluid responder if SV increases by > 10% after the fluid challenge (21). If the patient becomes a fluid non-responder, vasopressor infusion or inotrope will start. | Device: Assessment of fluid responsiveness by electrical cardiometry<br>* Electrical cardiometry (EC) measurements: by the ICON_ hemodynamic monitor (ICON Cardiotropic, Inc., La Jolla, CA 92307; Osyka Medical GmbH, Berlin, and Germany, model C3). Transthoracic echocardiography (TTE) measurements will be performed equipped with echo probe. SV of the left ventricle will be calculated using LVOT diameter (D) just below the aortic valve from parasternal long-axis view and VTI measured in LVOT from apical 5 chamber view (by pulsed wave Doppler).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of Electrical cardiometry (EC) to predict fluid responsiveness | Electrical cardiometry will be done be done immediately before fluid resuscitation and every 30 min till mean arterial pressure (MAP) > 65 mmHg | Intraoperative and every 30 minutes till MAP>65mmHg | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Agreement of Electrical cardiometry(EC) with Transthoracic echocardiography (TTE) in the change of stroke volume before and after fluid challenge | Fluid resuscitation will be done by intravenous infusion of lactated ringer guided by fluid responsiveness (fluid responder if SV increases by > 10% after the fluid challenge. If the patient becomes fluid non-responder, vasopressor infusion or inotrope will start. The end of the study is when mean arterial pressure (MAP) > 65 mmHg (either by fluid or both fluid and vasopressor). | Intraoperatively. |