Outcomes
SECONDARY
In this post-hoc analysis, patients were grouped by the NED at study drug initiation into low (≤ 0.25 µg/kg/min) and high (> 0.25 µg/kg/min) subgroups. This cut-off was established on the basis of post-marketing observational studies demonstrating that 0.2–0.3 µg/kg/min NED is a common criterion in local hospital protocols for adding AT II [Within each subgroup, we compared the differences in 28-day survival between patients receiving AT II or placebo. The primary outcome was the difference in 28-day survival between the AT II and placebo groups in those with a baseline NED ≤ 0.25 µg/kg/min at the time of study drug initiation. The secondary outcome was the difference in 28-day survival between the two groups in those with a baseline NED > 0.25 µg/kg/min. Other exploratory outcomes included the proportion of patients achieving a MAP response at hour 3, the degree of change in background vasopressors at hour 3, survival at 7 days, and cumulative incidence of discontinuation of renal replacement therapy (RRT) at 7 days. Safety was assessed and reported through 28 days.