Intervention With Concentrated Albumin for Undifferentiated Sepsis in the Emergency Department (ICARUS-ED): A Pilot Randomized Controlled Trial.

Study Objectives: Concentrated albumin early in sepsis resuscitation remains largely unexplored. Objectives were to determine 1) feasibility of early intervention with concentrated albumin in emergency department (ED) patients with suspected infection and hypoperfusion and 2) whether early albumin therapy improves outcomes.

Methods: ED patients with suspected infection and hypoperfusion (systolic blood pressure [SBP]<90 mmHg or lactate ≥4.0 mmol/L) were randomized to receive either 400 mL 20% albumin over 4 hours or no albumin. All patients were treated with crystalloids, antibiotics, and other therapies at the treating team's discretion. Primary outcome was SBP at 24 hours; secondary outcomes included SBP at 6 hours, fluid and organ support requirements, organ dysfunction, and mortality. Quantile and logistic regressions were used to calculate differences (and 95% CI) between study groups.

Results: Compliance with study protocol was more than 95%, and infection was confirmed in 95% of the 464 study patients enrolled. SBP at 24 hours did not differ between intervention (110.5 mmHg) and standard care arms (110 mmHg). In patients treated with albumin, SBP was higher at 6 hours, less total fluid was infused at 72 hours, fewer patients required vasopressor therapy at 24 and 72 hours, and organ function was improved. Mortality was not significantly different.

Conclusions: Early identification, trial enrollment, and intervention in ED patients with sepsis is feasible. In this pilot study, concentrated albumin given early in resuscitation did not improve SBP at 24 hours. Albumin was associated with less total fluid and vasopressor requirements and improved organ dysfunction. A multicenter study is indicated.