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

April 17, 2025 updated by: University Hospital, Montpellier

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

55

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
    • Occitanie
      • Montpellier, Occitanie, France, 34090

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
study cohort
Adult patients at the early phase of a cardiogenic shock treated with veno-arterial ECMO (<48h)
Other: 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%)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
optimal flow
Time Frame: 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).
Day 1 (ECMO initiation), Day 2 (24 hours after ECMO initiation), and Day 3 (48 hours after ECMO initiation).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
optimal flow according to echocardiography
Time Frame: 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).
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
Time Frame: 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).
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)
Time Frame: 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).
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)
Time Frame: 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).
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
Time Frame: 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).
Day 1 (ECMO initiation), Day 2 (24 hours after ECMO initiation), and Day 3 (48 hours after ECMO initiation).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Investigators

  • Principal Investigator: Aurore Ughetto, MD, Montpellier University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 15, 2025

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

March 26, 2025

First Submitted That Met QC Criteria

April 17, 2025

First Posted (Actual)

April 20, 2025

Study Record Updates

Last Update Posted (Actual)

April 20, 2025

Last Update Submitted That Met QC Criteria

April 17, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHMPL24_0215

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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