Precision Resuscitation With Crystalloids in Sepsis

NCT06253585 | Completed DMC

• 2 other identifiers: STUDY000067952025P010771
• Study Type: interventional
• Target: 2,012
• Locations: 1 country
• Sites: 7

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.

Conditions

Sepsis

Keywords

Algorithm; Fluids; Infection; Crystalloids; Normal Saline

Outcome Measures

Primary Outcomes (1)

• Thirty-day mortality

  Thirty-day mortality

  30 days

Secondary Outcomes (6)

• Intensive care unit (ICU) admission

  Duration of hospital stay up to 30 days

• In-hospital mortality

  Duration of hospital stay, up to 30 days

• Use of vasoactive drugs

  Duration of hospital stay up to 30 days

• New renal replacement therapy (RRT)

  Duration of hospital stay up to 30 days

• Mechanical ventilation

  Duration of hospital stay up to 30 days

Study Arms (2)

EHR Alert

EXPERIMENTAL

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

Standard of Care

ACTIVE COMPARATOR

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

Interventions

Algorithm Alarm- Crystalloids 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).

Also known as: Intervention Group

EHR Alert

Standard of Care 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.

Also known as: Usual Care

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Emory University: lead

Study Sites (7)

Emory Midtown Hospital

Atlanta, Georgia, 30308, United States

Location

Emory Saint Joseph's Hospital

Atlanta, Georgia, 30308, United States

Location

Emory Healthcare System

Atlanta, Georgia, 30322, United States

Location

Emory Hospital

Atlanta, Georgia, 30322, United States

Location

Emory Decatur Hospital

Decatur, Georgia, 30033, United States

Location

Emory Johns Creek Hospital

Johns Creek, Georgia, 30097, United States

Location

Emory Hillandale Hospital

Lithonia, Georgia, 30058, United States

Location

Related Publications (1)

• 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.

  PMID: 39292459 DERIVED

MeSH Terms

Conditions

Sepsis; Infections

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Sivasubramanium Bhavani, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: February 12, 2024
• Study Start: June 13, 2024
• Primary Completion: December 19, 2025
• Study Completion: December 19, 2025
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be shared beginning 6 months after publication, without a specified end date.
• 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.

Locations

US (7)