The Precision Resuscitation With Crystalloids in Sepsis (PRECISE) Trial: A Trial Protocol

Area of Science:

• Critical Care Medicine
• Precision Medicine
• Clinical Trials

Background:

• Intravenous fluid selection in sepsis treatment lacks consensus.
• A specific sepsis subphenotype (group D) shows improved outcomes with balanced crystalloids over normal saline.

Purpose of the Study:

• To evaluate if electronic health record (EHR) alerts promoting balanced crystalloids reduce 30-day mortality in group D sepsis patients.
• To test the hypothesis that EHR-guided fluid resuscitation improves sepsis outcomes.

Main Methods:

• The Precision Resuscitation With Crystalloids in Sepsis (PRECISE) trial is a pragmatic randomized clinical trial across 6 hospitals.
• Patients with suspected group D sepsis receiving normal saline in the ED or ICU are randomized.
• An EHR alert prompts clinicians to use balanced crystalloids instead of normal saline.

Main Results:

• The primary outcome is 30-day inpatient mortality.
• Secondary outcomes include ICU admission, in-hospital mortality, and need for vasoactive drugs, kidney replacement therapy, or mechanical ventilation.
• Intention-to-treat analysis will be performed.

Conclusions:

• Precision resuscitation using a machine learning algorithm and EHR alerts could significantly impact sepsis fluid management.
• This approach has the potential to redefine international standards for intravenous fluid resuscitation in sepsis.