Comprehensive Summary
This ongoing pragmatic randomized trial evaluates whether an electronic health record (EHR) alert encouraging balanced crystalloids (rather than normal saline) for patients identified by a high-mortality sepsis subphenotype (group D) reduces 30-day inpatient mortality. The primary endpoint is 30-day inpatient mortality; secondary outcomes include intensive care unit admission, in-hospital mortality at any time, receipt of vasoactive agents, and other clinical measures.Results have not yet been reported, as patient enrollment and follow-up are ongoing. Notably, PRECISE represents one of the first precision-enrollment trials in sepsis resuscitation, leveraging real-time EHR phenotyping to guide fluid choice.
Outcomes and Implications
Globally, sepsis affects an estimated 48 million people each year and remains a leading cause of critical illness and death. Intravenous crystalloids are the cornerstone of initial sepsis resuscitation, but the benefit of balanced solutions over normal saline in specific high-risk phenotypes remains uncertain. Should the trial demonstrate a mortality benefit, its findings could inform future iterations of the Surviving Sepsis Guidelines and encourage broader adoption of phenotype-directed fluid strategies worldwide.