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

NCT06936839 | Not Yet Recruiting DMC

• 1 other identifier: RECHMPL24_0215
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

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).

Conditions

Cardiogenic Shock

Keywords

ECMO; optimal flow; cardiogenic shock; echocardiography; organ perfusion; myocardial recovery; human; adult; left ventricular overload

Outcome Measures

Primary Outcomes (1)

• optimal flow

  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).

  Day 1 (ECMO initiation), Day 2 (24 hours after ECMO initiation), and Day 3 (48 hours after ECMO initiation).

Secondary Outcomes (5)

• optimal flow according to echocardiography

  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

  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)

  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)

  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

  Day 1 (ECMO initiation), Day 2 (24 hours after ECMO initiation), and Day 3 (48 hours after ECMO initiation).

Study Arms (1)

study cohort

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

Other: Obversation

Interventions

Obversation OTHER

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%)

study cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with cardiogenic shock treated with VA ECMO for less than 48 hours without any of the exclusion criteria.

You may qualify if:

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

You may not qualify if:

• 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),
• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Montpellier University Hospital

Montpellier, Occitanie, 34090, France

Location

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MeSH Terms

Conditions

Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Study Officials

• Aurore Ughetto, MD

  Montpellier University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aurore Ughetto, MD

CONTACT

+33467335958; a-ughetto@chu-montpellier.fr

Philippe Gaudard, MD, PhD

CONTACT

+33467335958; p-gaudard@chu-montpellier.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 20, 2025
• Study Start: April 15, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: April 20, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)