Comprehensive Summary
This open-label, randomized controlled trial investigates whether early concentrated albumin therapy in emergency department (ED) patients with suspected sepsis and hypoperfusion is feasible and improves patient outcomes. At a single center, 464 patients were randomized 1:1 to albumin or no albumin, along with their standard of care. Compliance to the study protocol was achieved in 447 participants (>95%) and 440 patients (95%) had confirmed infection. The primary outcome was systolic blood pressure (SBP) at 24 hours. Secondary outcomes to evaluate early hemodynamic effects and clinical impact included SBP at 6 hours, fluid and organ support requirements, organ dysfunction, and mortality. The study did not meet its primary endpoint, finding no difference in SBP at 24 hrs between the treatment (110.5 mmHg) and control arm (110 mmHg). Furthermore, patients receiving albumin had a higher SBP after 6 hours and less total fluid infusion after 72 hours. Fewer needed vasopressor medication at 24 and 72 hours and organ function improved. Mortality was not significantly different between both groups, likely due to insufficient power for mortality outcomes.
Outcomes and Implications
The study suggests early hemodynamic intervention with albumin therapy in ED patients with suspected sepsis and hypoperfusion is feasible. The treatment may cause less fluid and vasopressor use and less organ dysfunction in the first 72 hours of care. However, as a single-center, unblinded study with insufficient power for mortality outcomes, the timeline for clinical implementation is uncertain. Multicenter studies need to confirm how early albumin therapy impacts outcomes in patients with sepsis.