Cardiogenic Shock
Conditions
Keywords
ECMO, optimal flow, cardiogenic shock, echocardiography, organ perfusion, myocardial recovery, human, adult, left ventricular overload
Brief summary
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).
Interventions
OTHERObversation
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%)
Sponsors
University Hospital, Montpellier
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| optimal flow | Day 1 (ECMO initiation), Day 2 (24 hours after ECMO initiation), and Day 3 (48 hours after ECMO initiation). | ECMO flow indexed to body surface area, defined as the flow with minimum PCWP (pulmonary capillary wedge pressure) and SvO2\>55% at different times after ECMO start (Day 1, day 2 and day 3). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| optimal flow according to echocardiography | Day 1 (ECMO initiation), Day 2 (24 hours after ECMO initiation), and Day 3 (48 hours after ECMO initiation). | ECMO flow indexed to body surface area, defined as the flow with minimum LVEDD (Left Ventricular End-Diastolic Diameter) and SvO2\>55% at different times after ECMO start (Day 1, day 2 and day 3). |
| optimal flow according to the patient's native cardiac output | Day 1 (ECMO initiation), Day 2 (24 hours after ECMO initiation), and Day 3 (48 hours after ECMO initiation). | ECMO flow indexed to body surface area, defined as the flow with optimized native cardiac output (measured or estimated by EtCO2 and arterial pulse pressure) at different times after ECMO start (Day 1, day 2 and day 3). |
| optimal flow in subgroup 1 (low pulse pressure) | Day 1 (ECMO initiation), Day 2 (24 hours after ECMO initiation), and Day 3 (48 hours after ECMO initiation). | Optimal flow as defined by the primary outcome in patients with low arterial pulse pressure (\<15mmHg) at different times after ECMO start (Day 1, day 2 and day 3). |
| optimal flow in subgroup 2 (normal pulse pressure) | Day 1 (ECMO initiation), Day 2 (24 hours after ECMO initiation), and Day 3 (48 hours after ECMO initiation). | Optimal flow as defined by the primary outcome in patients with normal arterial pulse pressure (\>15mmHg) at different times after ECMO start (Day 1, day 2 and day 3). |
| Correlation between flow and other perfusion indicators | Day 1 (ECMO initiation), Day 2 (24 hours after ECMO initiation), and Day 3 (48 hours after ECMO initiation). | test the correlation between flow rate and tissue perfusion indicators (SvO2, NIRSS, Respiratory quotient, CO2 gap). |
Countries
France
Contacts
Primary ContactAurore Ughetto, MD
Backup ContactPhilippe Gaudard, MD, PhD
Outcome results
None listed