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

Обзор

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).

Вмешательства

• Другое Obversation
  Observing the optimal flow rate to reduce left ventricular stress and enhance peripheral organ perfusion during ramp tests (conducted at QECMO levels of 100%, 75%, 50%, and 25%, provided that SVO₂ remains \>55% and NIRS rSO₂ remains \>50%)

Первичные конечные точки

• optimal flow [Срок оценки: Day 1 (ECMO initiation), Day 2 (24 hours after ECMO initiation), and Day 3 (48 hours after ECMO initiation).]

Вторичные конечные точки (5)

• optimal flow according to echocardiography [Срок оценки: Day 1 (ECMO initiation), Day 2 (24 hours after ECMO initiation), and Day 3 (48 hours after ECMO initiation).]
• optimal flow according to the patient's native cardiac output [Срок оценки: Day 1 (ECMO initiation), Day 2 (24 hours after ECMO initiation), and Day 3 (48 hours after ECMO initiation).]
• optimal flow in subgroup 1 (low pulse pressure) [Срок оценки: Day 1 (ECMO initiation), Day 2 (24 hours after ECMO initiation), and Day 3 (48 hours after ECMO initiation).]
• optimal flow in subgroup 2 (normal pulse pressure) [Срок оценки: Day 1 (ECMO initiation), Day 2 (24 hours after ECMO initiation), and Day 3 (48 hours after ECMO initiation).]
• Correlation between flow and other perfusion indicators [Срок оценки: Day 1 (ECMO initiation), Day 2 (24 hours after ECMO initiation), and Day 3 (48 hours after ECMO initiation).]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 1 центр

• Montpellier University Hospital — Montpellier

Публикации

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Идентификаторы

NCT: NCT06936839 · RECHMPL24_0215

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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