Precision Resuscitation With Crystalloids in Sepsis (PRECISE)

Precision Resuscitation With Crystalloids in Sepsis (PRECISE)

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 in 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sepsis
• Intervention / Treatment: Other: Algorithm Alarm- Crystalloids; Other: Standard of Care

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. Enrolled patients who are classified to Group D by the algorithm will be randomized within the electronic health record to either usual care or the intervention arm. In the intervention arm, if a physician 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. If a randomized patient is subsequently discharged from the emergency department or admitted to the general medicine wards, the patient will not be included in the primary analysis and the intervention will not continue. 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 ICU hospitalization. The intervention is necessarily unblinded when a clinician receives an alert when ordering normal saline on study patients.

• Study Type: Interventional
• Enrollment (Estimated): 1115
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sivasubramanium Bhavani, MD; Phone Number: 404-712-2970; Email: sivasubramanium.bhavani@emory.edu

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Emory Saint Joseph's Hospital
    • Atlanta, Georgia, United States, 30308
      • Emory Midtown Hospital
    • Atlanta, Georgia, United States, 30322
      • Emory Hospital
    • Atlanta, Georgia, United States, 30322
      • Emory Healthcare System
    • Decatur, Georgia, United States, 30033
      • Emory Decatur Hospital
    • Johns Creek, Georgia, United States, 30097
      • Emory Johns Creek Hospital
    • Lithonia, Georgia, United States, 30058
      • Emory Hillandale Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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 physicians order normal saline on Group D patients randomized to intervention. In the intervention arm, if a physician 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).; Other Names: Intervention Group
Active Comparator: 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.	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 physicians will not have any feedback from the algorithm and will not know the Group classification of their patient or the recommended fluid type.; Other Names: Usual Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thirty-day mortality	Thirty-day mortality	30 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Emory University
• Investigators: Principal Investigator: Sivasubramanium Bhavani, MD, Emory University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: February 2, 2024
• First Submitted That Met QC Criteria: February 2, 2024
• First Posted (Actual): February 12, 2024

Study Record Updates

• Last Update Posted (Actual): February 12, 2024
• Last Update Submitted That Met QC Criteria: February 2, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Infection; Fluids; Algorithm; Crystalloids; Normal Saline
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia
• Other Study ID Numbers: STUDY00006795

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The investigators will share individual participant data that underlie the results reported in an article, after deidentification (text, tables, figures, and appendices).
• IPD Sharing Time Frame: Data will be shared beginning 6 months after publication, without a specified end date.
• IPD Sharing Access Criteria: Data will be shared with researchers who provide a methodologically sound proposal to achieve the aims in an approved proposal. Proposals should be directed to the primary investigator. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No