Precision Resuscitation With Crystalloids in Sepsis

Not Applicable

Suspended

• Conditions: Sepsis
• Interventions: Other: Algorithm Alarm- Crystalloids; Other: Standard of Care

• Registration Number: NCT06253585
• Lead Sponsor: Emory University

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.

Study Timeline

• Study First Submitted: 2024-02-02
• Study First Submitted QC: 2024-02-02
• Study First Posted: 2024-02-12
• Study Start: 2024-06-13
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-17
• Last Update Posted: 2024-10-21
• Primary Completion: 2025-05-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 2002

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

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Exclusion Criteria

• None

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EHR Alert	Algorithm Alarm- Crystalloids	Enrolled patients who are classified to Group D by the algorithm will be randomized within the electronic health record to the intervention arm.
Standard of Care	Standard of Care	Enrolled patients who are classified to Group D by the algorithm will be randomized within the electronic health record to usual care.

Primary Outcome Measures

Name	Time	Method
Thirty-day mortality	30 days	Thirty-day mortality

Secondary Outcome Measures

Name	Time	Method
Use of vasoactive drugs	Duration of hospital stay up to 30 days	Proportion of patients requiring vasoactive drugs during hospital admission.
Intensive care unit (ICU) admission	Duration of hospital stay up to 30 days	Rate of ICU admission
Mechanical ventilation	Duration of hospital stay up to 30 days	Proportion of patients requiring mechanical ventilation during hospital admission.
In-hospital mortality	Duration of hospital stay, up to 30 days	Rate of in-hospital mortality.
New renal replacement therapy (RRT)	Duration of hospital stay up to 30 days	Proportion of patients requiring (RRT) during hospital admission

Trial Locations

Locations (7)

Emory Midtown Hospital; 🇺🇸 Atlanta, Georgia, United States

Emory Saint Joseph's Hospital; 🇺🇸 Atlanta, Georgia, United States

Emory Healthcare System; 🇺🇸 Atlanta, Georgia, United States

Emory Hospital; 🇺🇸 Atlanta, Georgia, United States

Emory Decatur Hospital; 🇺🇸 Decatur, Georgia, United States

Emory Johns Creek Hospital; 🇺🇸 Johns Creek, Georgia, United States

Emory Hillandale Hospital; 🇺🇸 Lithonia, Georgia, United States