Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2025-12-24 @ 7:45 PM
NCT ID:
NCT04984603
Eligibility Criteria:
All patients who receive VA-ECMO support and mechanical ventilation for refractory cardiogenic shock or cardiac arrest of any etiology (acute myocardial infarction, end-stage dilated cardiomyopathy, heart surgery, fulminant myocarditis…) are screened.
Inclusion criteria are:
Decision to perform volume expansion made by the attending physician for one of the following reasons:
* Hypotension or attempt to reduce vasopressor dose
* Hypoperfusion (oliguria, skin mottling, hyperlactatemia)
* Suspected Low NCO
Exclusion criteria are
* Age less than 18 years
* Evidence of significant hypovolemia such as kicking drainage cannula
* Active hemorrhage
* Concomitant left ventricle assist device (Impella/ LVAD) or Intra-aortic balloon pump (IABP)
* Atrial or ventricular communication
* Significant aortic insufficiency
* Unsatisfactory cardiac echogenicity (an inability to correctly align the Doppler beam to generate reliable VTI measurements at the left ventricular outflow tract (LVOT)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04984603
Study Brief:
Protocol Section:
NCT04984603