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:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07461961
Eligibility Criteria:
Inclusion Criteria:
Age ≥ 18 and ≤ 80 years.
Hospitalized in the Intensive Care Unit (ICU).
Cardiogenic shock defined by clinical and hemodynamic criteria.
Hypotension defined by SBP \<90 mmHg for \>30 min, MAP \<60 mmHg for \>30 min, or requirement of vasopressors to maintain SBP ≥90 mmHg or MAP ≥60 mm Hg.
Hypoperfusion defined by altered mental state, cold extremities, livedo reticularis, urine output \<30 mL/h, or lactate ≥2 mmol/L.
If invasive hemodynamic monitoring is available, CI \<2.2 L/min/m2.
SCAI stage B or stage C at the time of screening.
For SCAI Stage B (Beginning Shock), clinical evidence of hemodynamic instability (including relative hypotension, a decline in SBP of ≥20-30 mmHg, or MAP \<20% from baseline, or tachycardia) without hypoperfusion (normal lactate).
For SCAI Stage B, hypotension SBP \<90 mmHg or MAP \<60 mmHg or \> 30 mmHg drop from baseline, or tachycardia heart rate ≥100 bpm.
For SCAI Stage C, requiring only one vasoactive/inotrope and/or IABP from admission with CS until randomization, AND Vasoactive-inotropic score (VIS) \<40.
For SCAI Stage C, NONE of the following criteria of deterioration from admission until randomization: failure to respond to initial single vasopressor/inotrope drug and addition of a second drug, or failure to respond to IABP and need for new MCS device.
For SCAI Stage C, use of vasoactive agents at the time of randomization must not show: low starting dose with escalation, intermediate starting dose without escalation or de-escalation, or high starting dose with de-escalation.
For SCAI Stage C, worst lactate 2 - 5 mmol/L and increase ≥ 100% from baseline lactate ≥ 2mmol/L or worst lactate ≥5mmol/L.
Documented history of chronic heart failure with reduced ejection fraction (LVEF \<40%).
Etiology of cardiogenic shock must be congestive heart failure decompensation (HF-CS).
hsCRP ≥20 mg/L, reflecting a pro-inflammatory state.
Less than 48 hours since admission
Exclusion Criteria:
Cardiogenic shock caused by acute myocardial infarction (AMI-CS).
Other special conditions causing cardiogenic shock, including post-cardiotomy CS, peripartum, adrenergic, valvular, restrictive, post-embolic, conduction or rhythm disorders, or related to cardiotropic drug intoxication.
Circulatory shock of another cause, such as septic, hemorrhagic, or anaphylactic shock.
Shock post-cardiac arrest.
Onset of cardiogenic shock \>48 hours.
SCAI stage A, D, or E at the time of enrollment.
Severe hyperglycemia at baseline, defined as blood glucose ≥300 mg/dL despite insulin therapy.
Ongoing uncontrollable infection, suspected concomitant sepsis, or mixed septic-cardiogenic shock.
Ischemic hepatitis or ALT \>500 IU/L due to causes other than suspected hypoperfusion.
Severe refractory acute kidney injury (AKI) at baseline, defined as new persistent anuria (urine output \<50 mL/day) or refractory AKI requiring new emergent renal replacement therapy.
Known allergy to methylprednisolone or other steroid analogues.
Cardiac transplant patient or on the transplant list.
Patient planned for implantation of a durable LVAD.
Moribund patients (SAPS2 \>90) or predicated mortality \>90% within 30 days.
Signs of extremis, including lactate \>5 mmol/L, pH \<7.2, or refractory shock requiring escalation to \>3 vasopressors at screening.
Pregnant woman, parturient, or breastfeeding mother.
Adult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07461961
Study Brief:
Protocol Section:
NCT07461961