Precision Resuscitation With Crystalloids in Sepsis

NCT ID: NCT06253585

Last Updated: 2025-03-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 2002 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-13
• Study Completion Date: 2026-03-31

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.

Conditions

Sepsis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

EHR Alert

Enrolled patients who are classified to Group D by the algorithm will be randomized within the electronic health record to the intervention arm.

Group Type: EXPERIMENTAL

Algorithm Alarm- Crystalloids

Intervention Type: OTHER

The study uses an algorithm implemented within the Electronic Health Record (EHR). This algorithm identifies patients who belong to a sepsis subphenotype known as "Group D", in whom published data has shown a mortality benefit from balanced crystalloids compared to normal saline.

The intervention is an EHR alert when clinicians order normal saline on Group D patients randomized to intervention. 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).

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.

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: OTHER

Enrolled patients who are classified to Group D by the algorithm will be randomized within the electronic health record to usual care. In the usual care arm, the clinicians will not have any feedback from the algorithm and will not know the Group classification of their patient or the recommended fluid type.

Interventions

Algorithm Alarm- Crystalloids

The study uses an algorithm implemented within the Electronic Health Record (EHR). This algorithm identifies patients who belong to a sepsis subphenotype known as "Group D", in whom published data has shown a mortality benefit from balanced crystalloids compared to normal saline.

The intervention is an EHR alert when clinicians order normal saline on Group D patients randomized to intervention. 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).

Intervention Type: OTHER

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. In the usual care arm, the clinicians will not have any feedback from the algorithm and will not know the Group classification of their patient or the recommended fluid type.

Intervention Type: OTHER

Other Intervention Names

Intervention Group; Usual Care

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Siva Bhavani

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sivasubramanium Bhavani, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory Midtown Hospital

Atlanta, Georgia, United States

Site Status: RECRUITING

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States

Site Status: RECRUITING

Emory Healthcare System

Atlanta, Georgia, United States

Site Status: RECRUITING

Emory Hospital

Atlanta, Georgia, United States

Site Status: RECRUITING

Emory Decatur Hospital

Decatur, Georgia, United States

Site Status: RECRUITING

Emory Johns Creek Hospital

Johns Creek, Georgia, United States

Site Status: RECRUITING

Emory Hillandale Hospital

Lithonia, Georgia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sivasubramanium Bhavani, MD

Role: CONTACT

sivasubramanium.bhavani@emory.edu

404-712-2970

Facility Contacts

Sivasubramanium Bhavani, MD

Role: primary

sivasubramanium.bhavani@emory.edu

404-501-1000

Sivasubramanium Bhavani, MD

Role: primary

sivasubramanium.bhavani@emory.edu

404-712-2970

Sivasubramanium Bhavani, MD

Role: primary

sivasubramanium.bhavani@emory.edu

404-501-8000

References

Bhavani SV, Holder A, Miltz D, Kamaleswaran R, Khan S, Easley K, Murphy DJ, Franks N, Wright DW, Kraft C, Semler MW, Churpek MM, Martin GS, Coopersmith CM. The Precision Resuscitation With Crystalloids in Sepsis (PRECISE) Trial: A Trial Protocol. JAMA Netw Open. 2024 Sep 3;7(9):e2434197. doi: 10.1001/jamanetworkopen.2024.34197.

Reference Type: DERIVED

PMID: 39292459 (View on PubMed)

Other Identifiers

STUDY00006795

Identifier Type: -

Identifier Source: org_study_id