Clinical Research Directory

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).