Echocardiographic Measurement of Myocardial Work

Not Applicable

Not yet recruiting

• Conditions: Intensive Care Unit Syndrome; Cardiovascular Physiological Phenomena
• Interventions: Other: Fluid administration; Other: Norepinephrine administration or increase in norepinephrine dosage

• Registration Number: NCT06422481
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

Brief Summary

Echocardiography is recommended for the hemodynamic management of patients with shock. Recently, a new echocardiographic method has been proposed that provides a non-invasive measurement of myocardial work incorporating different components, namely total myocardial work (GWI), constructive myocardial work (GCW), lost myocardial work (GWW) and effective myocardial work (GWE). Echocardiographic measurement of myocardial work takes into account both myocardial deformation and left ventricular afterload (estimated by measuring systolic blood pressure) and, unlike the measurement of left ventricular ejection fraction and global longitudinal strain, could be less dependent on cardiac load conditions, particularly left ventricular afterload. To date, non-invasive measurement of myocardial work has never been validated in critically ill patients, and no study has assessed the effects of different therapies (fluids administration, administration of norepinephrine) on the different components of myocardial work in patients admitted to intensive care unit.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-06
• Study First Submitted QC: 2024-05-14
• Last Update Submitted: 2024-05-14
• Study First Posted: 2024-05-21
• Last Update Posted: 2024-05-21
• Study Start: 2024-07
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• Indication to fluid administration left to the discretion of the attending physician
• Indication to norepinephrine administration or increase in norepinephrine dosage left to the discretion of the attending physician.

Exclusion Criteria

• Patients under protection.
• Patients with do not ressuscitate order.
• Patients with severe left-side or right-side valvulopathy.
• Patients with atrial fibrillation.
• Patients with ventricular aneuvrysm or severe regional wall motion abnormalities.
• Patients with a pacemaker.
• Patients' objections to the collection of their health data.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluids	Fluid administration	-
Norepinephrine	Norepinephrine administration or increase in norepinephrine dosage	-

Primary Outcome Measures

Name	Time	Method
Determine the feasibility of echocardiographic measurement	through study completion, an average of 1 year	The primary outcome will be assess by evaluating the proportion of patients in whom non-invasive echocardiographic measurement of myocardial work is obtained.

Secondary Outcome Measures

Name	Time	Method
measurement of myocardial by cardiac ultrasound during fluid administration	through study completion, an average of 1 year	The measurement of myocardial work will be performed non-invasively by cardiac ultrasound.; The secondary outcomes will be assess the impact of fluid administration on the different components of myocardial work. as follows: (i) fluid-induced changes in the different components of myocardial work, (ii) concordance between changes in myocardial work and changes in cardiac output induced by fluid administration (iii), the ability of the different components of myocardial work to predict fluid responsiveness.
measurement of myocardial by cardiac ultrasound norepinephrine administration	through study completion, an average of 1 year	The measurement of myocardial work will be performed non-invasively by cardiac ultrasound.; The secondary outcomes will be assess the impact of norepinephrine administration on the different components of myocardial work. as follows: (i) norepinephrine-induced changes in the different components of myocardial work, (ii) concordance between changes in myocardial work and changes in cardiac output induced by norepinephrine and (iii), the ability of the different components of myocardial work to predict fluid responsiveness.

Trial Locations

Locations (3)

CHU de NICE ARCHET; 🇫🇷 Nice, CHU De Nice, France

CHU de NICE PASTEUR; 🇫🇷 Nice, CHU De Nice, France

Aphm Hopital La Timone; 🇫🇷 Marseille, France