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

Not yet recruiting

• Conditions: Cardiogenic Shock

• Registration Number: NCT06936839
• Lead Sponsor: University Hospital, Montpellier

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-26
• Status Verified: 2025-04
• Study Start: 2025-04-15
• Study First Submitted QC: 2025-04-17
• Last Update Submitted: 2025-04-17
• Study First Posted: 2025-04-20
• Last Update Posted: 2025-04-20
• Primary Completion: 2026-04-01
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Montpellier University Hospital; 🇫🇷 Montpellier, Occitanie, France