Echocardiographic Measurement of Myocardial Work (MYOLOAD)

May 14, 2024 updated by: Centre Hospitalier Universitaire de Nice

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Marseille, France
        • Aphm Hopital La Timone
        • Contact:
        • Principal Investigator:
          • CYRIL NAFATI, MD
    • CHU De Nice
      • Nice, CHU De Nice, France, 06000
        • CHU de NICE ARCHET
        • Contact:
        • Principal Investigator:
          • THOMAS CITTI
      • Nice, CHU De Nice, France, 06000
        • CHU de NICE PASTEUR
        • Contact:
        • Principal Investigator:
          • DENIS DOYEN, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Norepinephrine
Other: 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.
Experimental: Fluids
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine the feasibility of echocardiographic measurement
Time Frame: 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.
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
measurement of myocardial by cardiac ultrasound during fluid administration
Time Frame: 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.
through study completion, an average of 1 year
measurement of myocardial by cardiac ultrasound norepinephrine administration
Time Frame: 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.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

May 6, 2024

First Submitted That Met QC Criteria

May 14, 2024

First Posted (Actual)

May 21, 2024

Study Record Updates

Last Update Posted (Actual)

May 21, 2024

Last Update Submitted That Met QC Criteria

May 14, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-PP-04

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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