Follow-up and outcomes
death, RIFLE, hypotension, renal damage, hypokalemia, VFDs
EVENTS, EVENT, HYPERNATREMIA
The primary outcome was 60-day all-cause mortality. Vital status and date of event in case of death were extracted from medical records or collected by investigators by phone calls to patients or their family.Secondary outcomes were 28-day and in-hospital all-cause mortality; MVFDs, defined as the cumulative number of days alive with no mechanical ventilation between Day 0 and Day 28; vasopressor-free days (VFDs), defined as the cumulative number of days alive with no prescription between Day 0 and Day 28; and renal replacement therapy-free days (RRTFDs), defined as the cumulative number of days alive with no renal replacement therapy between Day 0 and Day 60. Patients dying within the assessment intervals, and who were under mechanical ventilation, vasopressor prescription, or renal replacement therapy at the time of death, were assigned a count of zero free days, respectively, for the variable of interest.Safety outcomes consisted of unexpected harmful events occurring at least once between Day 2 and Day 14: arterial hypotension, defined as arterial systolic pressure < 90 mmHg; hypernatremia, defined as serum sodium level > 155 mmol/L; hypokalemia, defined as serum potassium level < 2.8 mmol/L; renal damage, defined by a worsening in the RIFLE criteria during Day 3–Day 14 compared to the higher RIFLE criteria during Day 1 and Day 2 [