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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06075407
Enrollment
50
Registered
2023-10-10
Start date
2023-04-29
Completion date
2023-09-01
Last updated
2023-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Electrical Cardiometry, Fluid Resuscitation, Shock, Transthoracic Echocardiography

Brief summary

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

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

Interventions

DEVICEAssessment of fluid responsiveness by electrical cardiometry

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).

Sponsors

Al-Azhar University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic accuracy of Electrical cardiometry (EC) to predict fluid responsivenessIntraoperative and every 30 minutes till MAP>65mmHgElectrical cardiometry will be done be done immediately before fluid resuscitation and every 30 min till mean arterial pressure (MAP) \> 65 mmHg

Secondary

MeasureTime frameDescription
Agreement of Electrical cardiometry(EC) with Transthoracic echocardiography (TTE) in the change of stroke volume before and after fluid challengeIntraoperatively.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).

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026