Crystalloids for Sepsis

(PRECISE Trial)

Recruiting at 6 trial locations

Overseen By Sivasubramanium Bhavani, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

2002 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether normal saline or balanced crystalloids better treat patients with sepsis, a serious infection that spreads throughout the body. Researchers have developed an algorithm that uses vital signs like temperature and heart rate to identify patients who might benefit more from balanced crystalloids. Participants will be divided into two groups: one receiving a prompt for balanced crystalloids and the other receiving usual care. Patients who visit the emergency room, have a blood culture ordered, and are classified by the algorithm as needing fluids are suitable candidates for this study. As an unphased trial, this study offers patients the opportunity to contribute to important research that could improve sepsis treatment options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this algorithm is safe for sepsis patients?

Research has shown that balanced crystalloids, a type of fluid used to treat sepsis, may be safer for patients. Some studies highlight their benefits, particularly for survival and kidney protection. For example, one study found these fluids help protect kidneys and improve survival rates in patients with sepsis.

Additionally, evidence suggests that balanced crystalloids might lead to fewer complications compared to other fluids, including a lower chance of needing kidney replacement therapy or experiencing irregular heartbeats.

Overall, balanced crystalloids appear well-tolerated with fewer side effects, making them a promising option for fluid therapy in sepsis treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the use of an algorithm-based alert system within electronic health records to optimize the use of crystalloids for treating sepsis. Unlike the standard of care, which generally involves a more generic approach to fluid resuscitation, this trial aims to personalize treatment by using real-time data to make decisions. This method could potentially enhance patient outcomes by ensuring that interventions are more precisely tailored to individual needs, minimizing risks and maximizing effectiveness.

What evidence suggests that this algorithm is effective for sepsis?

Research has shown that balanced crystalloids might work better than normal saline for treating sepsis. One study found that using balanced crystalloids instead of saline lowered death rates in sepsis patients. Another study demonstrated that balanced crystalloids were more effective than both saline and low molecular weight hydroxyethyl starch. Overall, balanced crystalloids seem to improve survival, suggesting they could be a better option for treating sepsis. In this trial, participants will be randomized to receive either an EHR Alert intervention involving balanced crystalloids or standard care to further evaluate their effectiveness in treating sepsis. ^{2 3 4 5 6}

Who Is on the Research Team?

Sivasubramanium Bhavani, MD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for adult patients in the emergency department who are suspected of having sepsis, as indicated by a blood culture order, and fall into a specific group (Group D) identified by an algorithm using vital signs. There are no exclusion criteria specified.

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

Not applicable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Intervention

Patients are randomized to receive either balanced crystalloids or usual care with normal saline, with EHR alerts prompting changes in fluid choice for Group D patients.

Up to 30 days

Continuous monitoring in the emergency department and ICU

Follow-up

Participants are monitored for safety and effectiveness after treatment, including 30-day mortality and other secondary outcomes.

30 days

What Are the Treatments Tested in This Trial?

Interventions

• Algorithm Alarm- Crystalloids

Trial Overview The study tests whether an algorithm can help doctors decide when to use balanced crystalloids instead of normal saline for treating sepsis. Patients in Group D will be randomly chosen to either receive this new approach or continue with standard care.

How Is the Trial Designed?

Group I: EHR Alert Experimental Treatment 1 Intervention

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

Group II: Standard of Care Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Published Research Related to This Trial

In a review of 13 studies involving nearly 31,000 critically ill adults, balanced crystalloids were associated with lower hospital and 28-/30-day mortality rates compared to 0.9% sodium chloride (saline), suggesting they may be a safer option for fluid resuscitation.

Balanced crystalloids also resulted in a lower incidence of new acute kidney injury compared to saline, indicating they may be more effective in protecting kidney function during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Balanced Crystalloids Versus Saline in Critically Ill Adults: A Systematic Review and Meta-analysis. Hammond, DA., Lam, SW., Rech, MA., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6909845/

Balanced Crystalloids versus Saline in Sepsis. A ... These findings suggest that balanced crystalloids may be more effective resuscitation fluids than saline for sepsis. Sepsis is a common illness for which few ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0735675725003766

Fluid resuscitation management in patients with sepsis and ... Balanced crystalloids (BC) demonstrated superior efficacy over low molecular weight hydroxyethyl starch (L-HES) (RR -0.84; 95 % CrI [0.75, 0.95]) and saline ( ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2823675

The Precision Resuscitation With Crystalloids in Sepsis ... Baseline variables, liters of crystalloid fluids administered, and outcomes will be collected on all randomized patients. After study completion ...

4. nejm.org nejm.org/doi/full/10.1056/NEJMoa2212663

Early Restrictive or Liberal Fluid Management for Sepsis ... The restrictive fluid strategy that was used in this trial did not result in significantly lower (or higher) mortality before discharge home by day 90 than the ...

5. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2025.1543586/full

Fluid resuscitation in adults with severe infection and sepsis In 2024, an RCT involving 301 participants from 15 medical institutions demonstrated that balanced crystalloids resulted in lower mortality ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9719278/

Fluid Resuscitation in Patients Presenting with Sepsis The primary outcome of mortality at 48-hours post randomisation was 10.6%, 10.5% and 7.6%, respectively, in the albumin-bolus, saline-bolus, and ...