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NCT06936839Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 20 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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).

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
55 (estimated)
First submitted
26 Mar 2025
Start date
15 Apr 2025
Primary completion date
1 Apr 2026
Lead sponsor
University Hospital, Montpellier
NCT number
NCT06936839

What you commit to

  • Study type: Observational
  • Planned participants: 55
  • From 15 Apr 2025 to the primary completion date, 1 Apr 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Cardiac arres prior to the cardiogenic shock with Low-Flow \> 30 min

Other illness

  • ECMO initiated for refractory cardiac arrest

Other

  • 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

Who the study is looking for

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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Montpellier University Hospital
Coordinator of this site? Confirm its status
MontpellierFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.