Echocardiographic Measurement of Myocardial Work

NCT06422481 | Not Yet Recruiting

• 1 other identifier: 24-PP-04
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 3

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.

Conditions

Cardiovascular Physiological Phenomena; Intensive Care Unit Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• measurement of myocardial by cardiac ultrasound during fluid administration

  through study completion, an average of 1 year

• measurement of myocardial by cardiac ultrasound norepinephrine administration

  through study completion, an average of 1 year

Study Arms (2)

Fluids

EXPERIMENTAL

Other: Fluid administration

Norepinephrine

EXPERIMENTAL

Other: Norepinephrine administration or increase in norepinephrine dosage

Interventions

Fluid administration OTHER

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.

Fluids

Norepinephrine administration or increase in norepinephrine dosage OTHER

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.

Norepinephrine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (3)

CHU de NICE ARCHET

Nice, CHU de Nice, 06000, France

Location

CHU de NICE PASTEUR

Nice, CHU de Nice, 06000, France

Location

Aphm Hopital La Timone

Marseille, France

Location

MeSH Terms

Interventions

Hypodermoclysis

Intervention Hierarchy (Ancestors)

Infusions, Subcutaneous; Infusions, Parenteral; Drug Administration Routes; Drug Therapy; Therapeutics; Fluid Therapy

Central Study Contacts

Mathieu Jozwiak, MD

CONTACT

+33492035510; jozwiak.m@chu-nice.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 21, 2024
• Study Start: July 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 21, 2024

Record last verified: 2024-05

Locations

FR (3)