CORTISHOCK-P: Trial of Corticosteroids in Inflammation-Enriched Heart Failure Cardiogenic Shock

Prior treatment

• Ongoing uncontrollable infection, suspected concomitant sepsis, or mixed septic-cardiogenic shock.
• 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.

Other illness

• 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.
• Shock post-cardiac arrest.
• Known allergy to methylprednisolone or other steroid analogues.
• Cardiac transplant patient or on the transplant list.

Lab values

• Severe hyperglycemia at baseline, defined as blood glucose ≥300 mg/dL despite insulin therapy.
• Ischemic hepatitis or ALT \>500 IU/L due to causes other than suspected hypoperfusion.
• Signs of extremis, including lactate \>5 mmol/L, pH \<7.2, or refractory shock requiring escalation to \>3 vasopressors at screening.

Other

• Circulatory shock of another cause, such as septic, hemorrhagic, or anaphylactic shock.
• Onset of cardiogenic shock \>48 hours.
• SCAI stage A, D, or E at the time of enrollment.
• Patient planned for implantation of a durable LVAD.
• Moribund patients (SAPS2 \>90) or predicated mortality \>90% within 30 days.
• Pregnant woman, parturient, or breastfeeding mother.
• Adult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice).

• 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