Patient race and ethnicity were included as demographic variables per standard study design and were determined for each patient by medical chart review. Other inclusion criteria included refractory hypotension, (mean arterial pressure ≤ 65 mm Hg after receiving ≥1 L and 3 L of IV fluid before random assignment, active “do not resuscitate” order, hemodynamic instability due to active hemorrhage, transferred from another hospital, acute cerebral vascular event, acute coronary syndrome, acute pulmonary edema, status asthmaticus, major cardiac arrhythmia, drug overdose, injury from burn or trauma, status epilepticus, indication for immediate surgery, inability or contraindication to PLR, pregnancy, or being incarcerated. We screened patients presenting to the ED with sepsis or septic shock (defined as ≥2 systemic inflammatory response syndrome (SIRS) criteria and a suspected or documented infection) and anticipated ICU admission. A full description of how patients were assigned randomly is provided in the supplementary material ( e-Appendix 1). We conducted a randomized unblinded clinical trial among adults with sepsis-associated hypotension to compare PLR-guided SV responsiveness as a guide for fluid management (intervention) vs usual care at 13 hospitals in the United States and the United Kingdom.
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