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

NCT06075407 | Completed

• 1 other identifier: 0345/2023
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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)

Conditions

Fluid Resuscitation; Electrical Cardiometry; Transthoracic Echocardiography; Shock

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Agreement of Electrical cardiometry(EC) with Transthoracic echocardiography (TTE) in the change of stroke volume before and after fluid challenge

  Intraoperatively.

Study Arms (2)

Fluid responder

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

Fluid non-responder

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

Interventions

Assessment of fluid responsiveness by electrical cardiometry DEVICE

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).

Fluid non-responder; Fluid responder

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged from 25 to 55 years old were intubated, with clinical criteria of shock (mean arterial pressure (MAP) ≤ 65 mmHg).

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Al-Azhar University

Cairo, 11651, Egypt

Location

MeSH Terms

Conditions

Shock

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist of Anesthesiology, Surgical Intensive Care and Pain Medicine

Study Record Dates

• First Submitted: October 4, 2023
• First Posted: October 10, 2023
• Study Start: April 29, 2023
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)