Echocardiographic Measurement of Myocardial Work

Intensive Care Unit Syndrome Clinical Trial

— MYOLOAD  

Official title:

Non-invasive Measurement of Myocardial Work Using Transthoracic Echocardiography in Critically Ill Patients: the MYOLOAD Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06422481
• Other study ID #: 24-PP-04
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: December 2025

Study information

• Verified date: May 2024
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Mathieu Jozwiak, MD
• Phone: +33492035510
• Email: jozwiak.m[@]chu-nice.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 110
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Physiological Phenomena
• Intensive Care Unit Syndrome

Intervention

Other:
• Fluid administration
Patients will receive fluid administration (500 mL of saline over 30 minutes). The indication of fluid administration will be left to the discretion of the attending physician.
• Norepinephrine administration or increase in norepinephrine dosage
Patients will receive norepinephrine or norepinephrine dosage will be increased if necessary to achieve the appropriate mean arterial pressure level. The indication of norepinephrine administration or increase in norepinephrine dosage will be left to the discretion of the attending physician.

Locations

Country	Name	City	State
France	Aphm Hopital La Timone	Marseille
France	CHU de NICE ARCHET	Nice	CHU De Nice
France	CHU de NICE PASTEUR	Nice	CHU De Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the feasibility of echocardiographic measurement	The primary outcome will be assess by evaluating the proportion of patients in whom non-invasive echocardiographic measurement of myocardial work is obtained.	through study completion, an average of 1 year
Secondary	measurement of myocardial by cardiac ultrasound during fluid administration	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.	through study completion, an average of 1 year
Secondary	measurement of myocardial by cardiac ultrasound norepinephrine administration	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.	through study completion, an average of 1 year