Precision Resuscitation With Crystalloids in Sepsis

Sepsis Clinical Trial

— PRECISE  

Official title:

Precision Resuscitation With Crystalloids in Sepsis (PRECISE)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06253585
• Other study ID #: STUDY00006795
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 3, 2024
• Est. completion date: May 31, 2025

Study information

• Verified date: May 2024
• Source: Emory University
• Contact: Sivasubramanium Bhavani, MD
• Phone: 404-712-2970
• Email: sivasubramanium.bhavani[@]emory.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

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 primary analysis is a modified-intention-to-treat analysis that analyzes the effect of the intervention on patients admitted to the intensive care unit. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1115
• Est. completion date: May 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Intervention

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).
• 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.

Locations

Country	Name	City	State
United States	Emory Healthcare System	Atlanta	Georgia
United States	Emory Hospital	Atlanta	Georgia
United States	Emory Midtown Hospital	Atlanta	Georgia
United States	Emory Saint Joseph's 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

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

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