SepsisPRECISENCT06253585
Precision Resuscitation With Crystalloids in Sepsis
A study testing Algorithm Alarm- Crystalloids in people with Sepsis, run by Emory University at 7 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- Algorithm Alarm- Crystalloids
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,012 participants
- Where
- 7 sitesUnited States
- Study dates
- 13 Jun 2024to 19 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Emory Midtown Hospital
Atlanta, Georgia, 30308
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30308
Emory Healthcare System
Atlanta, Georgia, 30322
Emory Hospital
Atlanta, Georgia, 30322
Emory Decatur Hospital
Decatur, Georgia, 30033
Emory Johns Creek Hospital
Johns Creek, Georgia, 30097
Emory Hillandale Hospital
Lithonia, Georgia, 30058
About this study
Official title: 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 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.
Read the 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
- Being tested
- Algorithm Alarm- Crystalloids, Standard of Care
- Keywords
- Algorithm, Fluids, Infection, Crystalloids, Normal Saline
- Medical subject headings
- Sepsis, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Algorithm Alarm- CrystalloidsOther
Also called Intervention Group
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 CareOther
Also called Usual 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thirty-day mortality
Thirty-day mortality
Measured: 30 days
Secondary outcomes (6)
Intensive care unit (ICU) admission
Rate of ICU admission
Measured: Duration of hospital stay up to 30 days
In-hospital mortality
Rate of in-hospital mortality.
Measured: Duration of hospital stay, up to 30 days
Use of vasoactive drugs
Proportion of patients requiring vasoactive drugs during hospital admission.
Measured: Duration of hospital stay up to 30 days
New renal replacement therapy (RRT)
Proportion of patients requiring (RRT) during hospital admission
Measured: Duration of hospital stay up to 30 days
Mechanical ventilation
Proportion of patients requiring mechanical ventilation during hospital admission.
Measured: Duration of hospital stay up to 30 days
EHR alert compliance
EHR alert compliance will be measured by the number of changes in clinician intravenous fluid ordering pattern after an EHR alert.
Measured: Duration of hospital stay up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start13 Jun 2024
- Primary completion19 Dec 2025
- Study completion19 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,012 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Siva Bhavani, Emory University
- Investigators
- Sivasubramanium Bhavani, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06253585
- Sponsor's protocol ID
- STUDY00006795
- Other IDs
- 2025P010771
- Acronym
- PRECISE
- Status last verified
- Mar 2026
- First submitted
- 2 Feb 2024
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators will share individual participant data that underlie the results reported in an article, after deidentification (text, tables, figures, and appendices).
Publications
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.
PubMed 39292459
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Resuscitation With Crystalloids in Sepsis (PRECISE)
- ClinicalTrials.gov ID
- NCT06253585
- Acronym / sponsor ID
- PRECISE / STUDY00006795
- Conditions
- Sepsis
- Keywords
- Algorithm, Fluids, Infection, Crystalloids, Normal Saline
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,012 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 13 Jun 2024 (actual)
- Primary completion
- 19 Dec 2025 (actual)
- Study completion
- 19 Dec 2025 (actual)
- First posted
- 12 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EHR Alert | Experimental | Other: Algorithm Alarm- CrystalloidsEnrolled 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 | Active comparator | Other: Standard of CareEnrolled patients who are classified to Group D by the algorithm will be randomized within the electronic health record to usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Algorithm Alarm- CrystalloidsAlso: Intervention GroupThe 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). | Other | EHR Alert |
| Standard of CareAlso: Usual CareEnrolled 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. | Other | Standard of Care |
Primary outcome
Thirty-day mortality
Time frame: 30 days
Thirty-day mortality
6 secondary outcomes
Intensive care unit (ICU) admission
Time frame: Duration of hospital stay up to 30 days
In-hospital mortality
Time frame: Duration of hospital stay, up to 30 days
Use of vasoactive drugs
Time frame: Duration of hospital stay up to 30 days
New renal replacement therapy (RRT)
Time frame: Duration of hospital stay up to 30 days
Mechanical ventilation
Time frame: Duration of hospital stay up to 30 days
EHR alert compliance
Time frame: Duration of hospital stay up to 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Derived from this study: PubMed 39292459Bhavani 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.
- Individual participant dataSharing planned: Yes. The investigators will share individual participant data that underlie the results reported in an article, after deidentification (text, tables, figures, and appendices).
Related trials for Sepsis
Not yet recruitingObservational study
Serum GDF-15 and LGALS3BP as Prognostic Biomarkers in Sepsis
Sepsis, Septic Shock
RecruitingPhase 3
A Trial of Adjunctive Fludrocortisone (50mcg, 100mcg or Placebo) in Critically Ill Patients With Septic Shock Receiving Hydrocortisone, Evaluating Survival and Functional Recovery and the Influence of Transcriptomic Response
Septic Shock
RecruitingObservational study
Middle East Study of Infections in Patients With Hematological Malignancies
Hematological Malignancy, Hematopoetic Stem Cell Transplantation
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Peer Bullying Intervention, Vodcast
Not yet recruitingObservational study
Comparative Study of the Genomic Characteristics of Uropathogenic Escherichia Coli According to the Severity of Community-Acquired Urinary Tract Infections in Guadeloupe (COLIGENURI)
Urinary Tract Infections
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sivasubramanium Bhavani, MD principal investigator
Emory University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Algorithm Alarm- Crystalloids in people with Sepsis, run by Emory University at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thirty-day mortality (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06253585, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.