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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Algorithm Alarm- Crystalloids for sepsis?

Research shows that using balanced crystalloids (a type of fluid given through an IV) instead of saline for sepsis patients can lower the risk of death within 30 days and reduce kidney problems. This suggests that balanced crystalloids might be a more effective treatment option for sepsis compared to saline. ^{1 2 3 4 5}

Is the use of crystalloids safe for treating sepsis?

Research shows that using balanced crystalloids in sepsis treatment is associated with lower death rates and fewer kidney problems compared to saline, suggesting it is generally safe for critically ill adults. ^{1 6 7 8 9}

How does the treatment Algorithm Alarm- Crystalloids differ from other treatments for sepsis?

The treatment using balanced crystalloids for sepsis is unique because it is associated with lower 30-day in-hospital mortality and fewer major adverse kidney events compared to using saline. This suggests that balanced crystalloids may be a safer and more effective option for fluid resuscitation in critically ill patients with sepsis. ^{1 3 7 10 11}

Research Team

Sivasubramanium Bhavani, MD

Principal Investigator

Emory University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Balanced Crystalloids versus Saline in Sepsis. A Secondary Analysis of the SMART Clinical Trial. [2022]

2. China pubmed.ncbi.nlm.nih.gov

[Colloids vs. crystalloids in fluid resuscitation for septic shock: a meta-analysis]. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

The Effect of Fluid Initiation Timing on Sepsis Mortality: A Meta-Analysis. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Early Fluid is Less Fluid: Comparing Early Versus Late Resuscitation in Severely Injured Trauma Patients. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Patterns and Outcomes Associated With Timeliness of Initial Crystalloid Resuscitation in a Prospective Sepsis and Septic Shock Cohort. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Effect of balanced crystalloids versus saline on urinary biomarkers of acute kidney injury in critically ill adults. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Adherence to fluid resuscitation guidelines and outcomes in patients with septic shock: Reassessing the "one-size-fits-all" approach. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Lower vs. higher fluid volumes in sepsis-protocol for a systematic review with meta-analysis. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

The impact of crystalloid and colloid infusion on the kidney in rodent sepsis. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Effects of Different Crystalloid Solutions on Hemodynamics, Peripheral Perfusion, and the Microcirculation in Experimental Abdominal Sepsis. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Balanced Crystalloids Versus Saline in Critically Ill Adults: A Systematic Review and Meta-analysis. [2020]