## Protocol Section
### Identification Module
**NCT ID:** NCT06422481

**Acronym:** MYOLOAD

**Brief Title:** Echocardiographic Measurement of Myocardial Work

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

#### Organization Study ID Info
**ID:** 24-PP-04
#### Organization
**Class:** OTHER
**Full Name:** Centre Hospitalier Universitaire de Nice
### Status Module
#### Completion Date
**Date:** 2025-12

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-14

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-07

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-06
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Centre Hospitalier Universitaire de Nice

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Cardiovascular Physiological Phenomena

- Intensive Care Unit Syndrome

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** BASIC_SCIENCE

#### Enrollment Info

**Count:** 110

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Other: Fluid administration

**Label:** Fluids

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Other: Norepinephrine administration or increase in norepinephrine dosage

**Label:** Norepinephrine

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Fluids

**Description:** 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.

**Name:** Fluid administration

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Norepinephrine

**Description:** 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.

**Name:** Norepinephrine administration or increase in norepinephrine dosage

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** The primary outcome will be assess by evaluating the proportion of patients in whom non-invasive echocardiographic measurement of myocardial work is obtained.

**Measure:** Determine the feasibility of echocardiographic measurement

**Time Frame:** through study completion, an average of 1 year

#### Secondary Outcomes

**Description:** 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.

**Measure:** measurement of myocardial by cardiac ultrasound during fluid administration

**Time Frame:** through study completion, an average of 1 year

**Description:** 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.

**Measure:** measurement of myocardial by cardiac ultrasound norepinephrine administration

**Time Frame:** through study completion, an average of 1 year

### Eligibility Module

**Eligibility Criteria:** 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.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** jozwiak.m@chu-nice.fr

**Name:** Mathieu Jozwiak, MD

**Phone:** +33492035510

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Nice

**Contacts:**

***Contact 1:***

- **Email:** jozwiak.m@chu-nice.fr

- **Name:** Mathieu Jozwiak, MD

- **Phone:** +33492035510

- **Role:** CONTACT

***Contact 2:***

- **Name:** THOMAS CITTI

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** France

**Facility:** CHU de NICE ARCHET

**State:** CHU De Nice

**Zip:** 06000

**Location 2:**

**City:** Nice

**Contacts:**

***Contact 1:***

- **Email:** doyen.d@chu-nice.fr

- **Name:** DENIS DOYEN, MD

- **Role:** CONTACT

***Contact 2:***

- **Name:** DENIS DOYEN, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** France

**Facility:** CHU de NICE PASTEUR

**State:** CHU De Nice

**Zip:** 06000

**Location 3:**

**City:** Marseille

**Contacts:**

***Contact 1:***

- **Email:** CYRIL.NAFATI@AP-HM.fr

- **Name:** CYRIL NAFATI, MD

- **Role:** CONTACT

***Contact 2:***

- **Name:** CYRIL NAFATI, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** France

**Facility:** Aphm Hopital La Timone

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M19010

- Name: Critical Illness

- Relevance: LOW

- As Found: Unknown

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Ancestors

- ID: D000000316

- Term: Adrenergic alpha-Agonists

- ID: D000000322

- Term: Adrenergic Agonists

- ID: D000018663

- Term: Adrenergic Agents

- ID: D000018377

- Term: Neurotransmitter Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000013566

- Term: Sympathomimetics

- ID: D000001337

- Term: Autonomic Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000014662

- Term: Vasoconstrictor Agents

### Intervention Browse Module - Browse Branches

- Abbrev: VaCoAg

- Name: Vasoconstrictor Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M12575

- Name: Norepinephrine

- Relevance: HIGH

- As Found: Kinase

- ID: M20746

- Name: Adrenergic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M3668

- Name: Adrenergic alpha-Agonists

- Relevance: LOW

- As Found: Unknown

- ID: M3673

- Name: Adrenergic Agonists

- Relevance: LOW

- As Found: Unknown

- ID: M20504

- Name: Neurotransmitter Agents

- Relevance: LOW

- As Found: Unknown

- ID: M16345

- Name: Sympathomimetics

- Relevance: LOW

- As Found: Unknown

- ID: M17409

- Name: Vasoconstrictor Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000009638

- Term: Norepinephrine

### Misc Info Module

- Version Holder: 2024-05-31
