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

Completed

• Conditions: Fluid Resuscitation; Electrical Cardiometry; Shock; Transthoracic Echocardiography
• Interventions: Device: Assessment of fluid responsiveness by electrical cardiometry

• Registration Number: NCT06075407
• Lead Sponsor: Al-Azhar University

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 EC"s 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

Study Timeline

• Study Start: 2023-04-29
• Primary Completion: 2023-09-01
• Study Completion: 2023-09-01
• Status Verified: 2023-10
• Study First Submitted: 2023-10-04
• Study First Submitted QC: 2023-10-04
• Study First Posted: 2023-10-10
• Last Update Submitted: 2023-10-19
• Last Update Posted: 2023-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fluid responder	Assessment of fluid responsiveness by electrical cardiometry	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.
Fluid non-responder	Assessment of fluid responsiveness by electrical cardiometry	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.

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of Electrical cardiometry (EC) to predict fluid responsiveness	Intraoperative and every 30 minutes till MAP>65mmHg	Electrical cardiometry will be done be done immediately before fluid resuscitation and every 30 min till mean arterial pressure (MAP) \> 65 mmHg

Secondary Outcome Measures

Name	Time	Method
Agreement of Electrical cardiometry(EC) with Transthoracic echocardiography (TTE) in the change of stroke volume before and after fluid challenge	Intraoperatively.	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).

Trial Locations

Locations (1)

Al-Azhar University; 🇪🇬 Cairo, Egypt