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Patients received structured diabetes education (2 × 3 hours) before randomization.
For the 24 hours before randomization, we collected the physiological variables, relevant therapeutic interventions, radiographic findings, co-morbidities, and medications.
After agreement to participate, patients were asked to remain in fasting conditions between 6 and 8 hours before randomization.
Baseline characteristics including demographics, history and type of infection, and laboratory test results were obtained within the 24 hours before randomization.
CDI was defined by a change in bowel habits, with >3 unformed bowel movements (or >200 mL unformed stool for subjects with rectal collection devices) during the 24 hours before randomization, and the presence of either C. difficile toxin A or B in the stool within 48 hours before randomization.
Previous vancomycin or metronidazole treatment in the 24 hours before randomization, low eosinophil count (<0.1 × 10/L), and low albumin level were independent predictors of persistent diarrhea or death in the first 12 days.
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Enrolled patients had at least one episode of atrial fibrillation in the prior 3 months and were in sinus rhythm for at least 1 hour before randomization.
Less severe septic shock was defined as infusion of 5 to 14 μg/minute norepinephrine (or equivalent) while more severe septic shock was defined as ≥15 μg/minute norepinephrine (or equivalent) in the hour before randomization.
In addition, we required a CT to have been conducted within 24 hours before inclusion of the patient in the study; intravenous administration of 0.7 g/kg mannitol 1 hour before randomization; or a plasmatic osmolarity measurement above 320 mOsm/kg, in order to ensure that hyperosmolar therapy had been optimized before inclusion.
Shock at randomization was defined as a mean arterial pressure of less than 70 mm Hg, the need for ongoing treatment with vasopressor or inotropic agents, or a plasma lactate level of more than 4.0 mmol per liter in the hour before randomization.
The APACHE II score is used to assess patients' risk of dying in the intensive care unit and is based on the most abnormal values observed in the 24 hours immediately before randomization.
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