Optimal ECMO Flow in the Critical Phase of Cardiogenic Shock to Optimize Peripheral Organ Perfusion and Myocardial Stress (ECMO-FLOW)

University Hospital Center (CHU)

Status: Not yet enrolling

Conditions: Cardiogenic Shock

Treatments: Other: Obversation

Study type: Observational

Funder types: Other

Identifiers

NCT06936839

RECHMPL24_0215

Details and patient eligibility

About

Veno-arterial ECMO (VA ECMO) is considered the ultimate lifesaving technique in refractory cardiogenic shock (CS). However, VA ECMO is associated with potentially serious adverse effects and complications. Many authors have demonstrated that VA ECMO increases left ventricular (LV) afterload, leading to increased LV stress, left ventricular end-diastolic pressure (LVEDP), and left atrial pressure (LAP). This pressure increase frequently results in pulmonary oedema and higher myocardial oxygen consumption. These complications are critical to patient survival and myocardial recovery and can lead to prolonged hospital stays and increased healthcare costs.

In the absence of clinical studies and strong recommendations, the optimized management of VA ECMO in clinical practice involves finding an ECMO flow that balances adequate organ perfusion with preserved ventricular ejection, while minimizing LV stress. Since the optimal flow changes with myocardial recovery, ramp tests are regularly performed to adjust ECMO flow.

To date, the optimized management of VA ECMO has been guided empirically. The aim of this study is to describe the consequences of variations in VA ECMO flow during the critical phase of cardiogenic shock on peripheral organ perfusion and LV stress. By analyzing the relationships between VA ECMO flow rate, peripheral perfusion, and myocardial stress, investigators aim to optimize flow settings-particularly by minimizing the potential complications of VA ECMO.

During the daily ramp tests, investigators plan to collect hemodynamic data (cardiac output, SvO₂, pulse pressure, EtCO₂, vasopressor and inotrope dosing), echocardiographic measurements, and organ perfusion indicators (NIRSS, CO₂ gap, respiratory quotient, lactate levels). Data will be collected on Day 1 (ECMO initiation), Day 2 (24 hours after ECMO initiation), and Day 3 (48 hours after ECMO initiation).

Enrollment: 55 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• cardiogenic shock
• treated with VA ECMO for less than 48hours

Exclusion criteria

• ECMO initiated for refractory cardiac arrest
• Cardiac arres prior to the cardiogenic shock with Low-Flow > 30 min
• Noradrenaline dose > 1μg/kg/min, vasopressin dose > 2IU/h, dobutamine dose > 15μg/kg/min, adrenaline dose > 1μg/kg/min, or unstabilized vasopressors or inotropes
• Post-cardiotomy cardiogenic shock
• Septic shock
• Left ventricular unloading by Impella (CP/5) or atrioseptostomy
• Atrial septal defect
• Ventricular septal defect
• Pregnant or breast-feeding women
• Patients protected by law (under guardianship or curatorship),
• Patient participating in another research study with an exclusion period still in progress
• Opposition to participation after having been informed
• Patient not affiliated to any health care system
• Patient unable to express non-opposition without available trusted person

Trial design

55 participants in 1 patient group

study cohort

Description:

Adult patients at the early phase of a cardiogenic shock treated with veno-arterial ECMO (\<48h)

Treatment:

Other: Obversation