Clinical trial NCT06253585: Precision Resuscitation With Crystalloids in Sepsis
Official title: Precision Resuscitation With Crystalloids in Sepsis (PRECISE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sepsis
Keywords: Algorithm
Fluids
Infection
Crystalloids
Normal Saline
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2024-02-12
Enrollment: 2002
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Fluids are one of the most common treatments given to patients in the hospital. Fluids are especially important in treating patients with sepsis. Multiple clinical studies have compared the two main types of fluids used in sepsis (normal saline and balanced crystalloids). However, these studies have not found a clear benefit of one type of fluid versus the other. Which fluid should be given to which patient is an essential question because of the ubiquity of this intervention. Even a small difference in mortality could drastically change the standards of care given the national (and worldwide) scale of this intervention. The investigators have developed an algorithm that uses bedside vital signs (temperature, heart rate, respiratory rate, and blood pressure) to identify a group of patients (Group D) who have a significant mortality benefit from balanced crystalloids. The study randomizes adult patients admitted through emergency departments across 6 Emory hospitals belonging to Group D to intervention versus usual care. The intervention arm involves a prompt to clinicians to use balanced crystalloids rather than normal saline.

Detailed description: In this study, the vitals trajectory algorithm will run on all adult patients presenting to the emergency department (ED) across the Emory Healthcare hospitals. Patients will be enrolled and eligible for randomization once they meet suspicion of infection criteria. Suspicion of infection is defined broadly as the ordering of blood cultures in the emergency department. Group D patients with a blood culture order in whom clinicians initiate a normal saline order will be randomized within the electronic health record to either usual care or the intervention arm. In the intervention arm, if a clinician orders normal saline in a patient classified as Group D, there will be an EHR alert to change the order to balanced crystalloids (i.e., Lactated Ringer or Plasma-Lyte solution). The alert will announce that preliminary data suggests a mortality benefit from balanced crystalloids in this patient and will ask the clinician whether there is a strong clinical indication to use normal saline.

The intervention is intended to start as early in the hospitalization as possible in the emergency department, as early crystalloid resuscitation choices may have effects on outcomes. The primary analysis is an intention-to-treat analysis (i.e., all patients randomized to intervention versus usual care regardless of whether the intervention resulted in a change in fluid choice). The intervention will be continued only for patients admitted from the emergency department to the intensive care unit. For patients in the intervention arm who are admitted to the ICU, the alert will fire every time normal saline is ordered till ICU discharge, death, or for up to 30 days of hospitalization. The intervention is necessarily unblinded when a clinician receives an alert when ordering normal saline on study patients.

Eligibility criteria: Inclusion Criteria:

* All adult patients presenting to the Emergency Department, with a blood culture order in the Emergency Department, who are classified as Group D, in whom a clinician initiates a normal saline order

Exclusion Criteria:

* None

Primary outcomes:
measure: Thirty-day mortality
timeFrame: 30 days
Secondary outcomes:
measure: Intensive care unit (ICU) admission
timeFrame: Duration of hospital stay up to 30 days
measure: In-hospital mortality
timeFrame: Duration of hospital stay, up to 30 days
measure: Use of vasoactive drugs
timeFrame: Duration of hospital stay up to 30 days
measure: New renal replacement therapy (RRT)
timeFrame: Duration of hospital stay up to 30 days
measure: Mechanical ventilation
timeFrame: Duration of hospital stay up to 30 days
measure: EHR alert compliance
timeFrame: Duration of hospital stay up to 30 days
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Midtown Hospital
state: Georgia
city: Atlanta
country: United States
facility: Emory Saint Joseph's Hospital
state: Georgia
city: Atlanta
country: United States
facility: Emory Healthcare System
state: Georgia
city: Atlanta
country: United States
facility: Emory Hospital
state: Georgia
city: Decatur
country: United States
facility: Emory Decatur Hospital
state: Georgia
city: Johns Creek
country: United States
facility: Emory Johns Creek Hospital
state: Georgia
city: Lithonia
country: United States
facility: Emory Hillandale Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Sivasubramanium Bhavani, MD
role: PRINCIPAL_INVESTIGATOR
References: