HYVAPRESS. HYdrocortisone and VAsopressine in Post-RESuscitation Syndrome

简要总结

主要结局

次要结局

• Vital status at day-30 Time to day-30 caused by irreversible cardiovascular failure defined as death in pharmacologically uncontrollable hypotension (mean arterial blood pressure <60 mmHg) despite maximal ICU care, or withdrawal of care based on same, as previously defined (Witten L, Resuscitation 2019)
• Time to day-30 caused by neurological withdrawal of care. Withdrawal of care will be based on expectations of a poor neurological recovery based on most recent guidelines (Sandroni C, ICM 2015).
• Time to day-30 by comorbid withdrawal of care. Comorbid withdrawal of care or refusal of lifesustaining therapy based on the expectation of a poor quality of life. This may be related to a preexisting or newly discovered terminal illness or other serious medical condition (e.g. dementia or cancer).
• Time to brain death (according to French legislation)
• Time to recurrent cardiac arrest-Proportion of patients dead from a cause not listed above
• Glasgow outcome score –extended at day-30. This score will be evaluated similarly to the primary endpoint
• Neuron-specific enolase (NSE) blood level measured 48 and 72 hours after CA
• Number of days between inclusion and day-30 without :catecholamines - norepinephrine - AVP - inotropic support
• Number of patients alive and free of norepinephrine at day-3, -5 and -7 Number of patients alive and free of AVP at day-3, - 5 and -7
• Proportion of patients with new onset of atrial fibrillation at day-30
• Left ventricular ejection fraction at day-1, 2, 3 and 7. Left ventricular ejection fraction will be evaluated using echocardiography (either trans-thoracic or trans-esophageal)
• Number of mechanical ventilation free days at day- 30
• Number of renal replacement therapy free days at day-30
• KDIGO classification at day-7 and day-30. The day- 30 KDIGO classification will be estimated on the creatinine criteria as theurine criteria will be unlikely available. The estimated glomerular filtration rate will becalculated using the MDRD equation.
• Proportion of patients with acute coronary syndrome defined according to the international guidelines (2015 ESC guidelines) as to know: the detection of an increase and/or a decrease of cardiac troponin and at least one of the following: (1) symptoms of ischemia, (2) new or presumed new significant ST-T wave changes or left bundle branch block on 12-lead ECG; (3) development of pathological Q waves on ECG, (4) imaging evidence of new or presumed new loss of viable myocardium or regional wall mot
• Proportion of patients with mesenteric ischemia at day-30, diagnosed on clinical assessment and a computed tomography angiography or endoscopy
• Proportion of patients with clinically diagnosed digital ischemia at day-30
• Proportion of patients with central diabetes insipidus at argipressin (AVP) weaning. Central diabetes insipidus is defined by a polyuria (> 50mL/kg/24h) associated with an increased plasmatic osmolality (> 300mOsm/L) and a decreased urinary osmolality (< 300mOsm/L)
• Proportion of patients with gastro-intestinal bleeding at day-30. Gastrointestinal bleeding will be diagnosed as a clinical gastrointestinal bleeding simultaneously with a drop of blood hemoglobin level
• Proportion of patients with hyperglycemia occurrence, defined as the number of episodes of blood glucose level higher than 11mmol/L between inclusion and day- 7
• ICU and hospital lengths of stay (in days)