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Table 1 Eligibility criteria

From: Low-dose corticosteroid therapy for cardiogenic shock in adults (COCCA): study protocol for a randomized controlled trial

Inclusion criteria

Exclusion criteria

1. Adult (age 18 years);

1. Cardiogenic shock state with catecholamine infusion for more than 24 h;

2. Cardiogenic shock state according to the following definition:

2. Presence of sepsis at inclusion;

a. Systemic arterial hypotension (SAP < 90 mmHg or MAP < 65 mmHg for 30 min) and/or low cardiac output requiring catecholamines to achieve a systolic blood pressure ≥ 90 mmHg;

3. Cardiac arrest recovered within 7 days prior to inclusion, with at least one of the following early signs of poor prognosis: no witness, non-shockable rhythm, CAHP score > 150 [16];

a. Sign of hypocontractility or low cardiac output among the following: cardiac index ≤ 2.2 L/min/m2, left ventricular ejection fraction (LVEF) ≤ 40%, or VTI LVOT ≤ 18 cm, or need for catecholamines to maintain adequate cardiac index, LVEF, or VTI LVOT;

4. Patients already on MCS before inclusion;

b. Signs of impaired organ perfusion with at least one of the following criteria:

5. Cardiogenic shock cause by viral myocarditis;

i. Altered mental status

6. Corticosteroid therapy within 4 weeks prior to inclusion;

ii. Skin mottling

7. Patient receiving one of the following treatments: ketoconazole, rifampicin, phenytoin, phenobarbital, cyclosporine, clarithromycin;

iii. Oliguria (≤ 25 ml/h)

8. Hypersensitivity to fludrocortisone or hydrocortisone;

iv. Increased serum lactate (> 2 mmol/L)

9. Pregnancy or breastfeeding;

c. Pulmonary congestion or elevated left-ventricular filling pressures

10. Privation of liberty by administrative or judicial decision;

3. Written informed consent from the patient or proxy (if present) before inclusion or once possible when patient has been included in a context of emergency;

11. Refusal of study participation or to pursue the study by the patient;

4. Benefiting of coverage by the French statutory healthcare insurance system.

  1. SAP systolic blood pressure, MAP mean arterial pressure, CAHP Cardiac Arrest Hospital Prognosis, VTI LVOT velocity-time integral of left ventricular outflow tract, MCS mechanical circulatory support