PRoMPT BOLUS: A Landmark PECARN Trial Defining Fluid Choice in Pediatric Sepsis

Two IV fluid bags labeled 0.9% sodium chloride and lactated Ringer's hanging side by side in a pediatric emergency department

Article reviewed: Balamuth F, Weiss SL, Long E, et al; PRoMPT BOLUS Investigators of the PECARN, PERC, and PREDICT Networks. Balanced Fluid or 0.9% Saline in Children Treated for Septic Shock. N Engl J Med. Published online April 24, 2026
DOI: 10.1056/NEJMoa2601969  |  PubMed: PMID 42028918

For years, clinicians and researchers have debated a fundamental question in pediatric emergency care: does the type of fluid used in pediatric sepsis resuscitation matter?

The PRoMPT BOLUS trial was designed to answer this question. Conducted across 47 international sites in 5 countries and enrolling more than 9,000 children, this large, pragmatic randomized trial compared 0.9% saline with balanced crystalloids in children treated for suspected septic shock.

The results have just been released. Across a wide range of clinically meaningful outcomes (including kidney injury, mortality, and recovery), there was no difference between fluid types.

Background

Sepsis remains a major global health concern, affecting approximately 50 million people each year, with children accounting for nearly half of these cases. Early fluid resuscitation is a cornerstone of treatment, making the choice of fluid a critical and historically debated decision.

Two primary types of crystalloid fluids are used in practice:

  • 0.9% saline, which contains a higher-than-physiologic chloride concentration
  • Balanced fluids (such as lactated Ringer’s, Hartmann’s solution and PlasmaLyte), which more closely resemble plasma electrolyte composition

Prior research raised concerns that saline could contribute to metabolic acidosis and kidney injury, while balanced fluids were associated with improved outcomes in some adult and smaller pediatric studies. However, the pediatric literature remained inconsistent, with observational studies reaching conflicting conclusions. As a result, guidelines offered only weak recommendations favoring balanced fluids and called for more definitive trials.

PRoMPT BOLUS was designed to fill this gap.

Study Design

This trial used a pragmatic, randomized design (NS vs. balanced fluids), intentionally embedded into routine clinical care. Pragmatic trials evaluate clinical interventions within typical practice, rather than highly controlled clinical settings. By incorporating fluid randomization without modifying additional aspects of clinical practice, this approach allowed investigators to study fluid choice in real-world conditions across diverse healthcare systems. PRoMPT BOLUS was a collaborative effort across multiple networks including PECARN (Pediatric Emergency Care Applied Research Network), PERC (Pediatric Emergency Research Canada), and PREDICT (Paediatric Research in Emergency Departments International Collaborative).

Children ages 2 months to <18 years were eligible if clinicians suspected sepsis and were planning to treat with more than one fluid bolus for abnormal perfusion consistent with septic shock. They were randomized to receive either balanced fluids or 0.9% saline, with clinicians otherwise managing care as they normally would.

The primary outcome was MAKE30 (Major Adverse Kidney Events within 30 days), a composite that includes mortality, need for renal replacement therapy, or persistent kidney dysfunction at hospital discharge or 30 days, whichever came first.

This pragmatic approach was critical to the study’s success. It allowed for:

  • High enrollment across multiple international sites
  • Enrollment at the beginning of sepsis resuscitation so that most early fluid was as randomized
  • Strong generalizability to everyday clinical practice
  • Minimal disruption to clinical workflows

Results

Primary Outcome

The primary outcome, MAKE30, occurred at nearly identical rates in both groups:

  • Balanced fluids: 3.4%
  • Saline: 3.0%

This difference was neither statistically nor clinically significant. There were also no differences in any of the individual MAKE30 components between treatment groups.

Secondary and Safety Outcomes

Similarly, there were no meaningful differences in:

  • Mortality
  • Hospital length of stay
  • Hospital-free days (median of 23 days in both groups)
  • Safety events such as thrombosis or cerebral edema

Together, these findings strongly support the conclusion that both fluids are equally safe and effective.

Biochemical Differences

Although there were measurable and statistically significant biochemical differences between groups (such as higher rates of hyperchloremia and hypernatremia with saline and hyperlactatemia with balanced fluids), these changes did not translate into clinically meaningful outcomes.

Subgroup Analyses

Subgroup analyses across patient characteristics, illness severity, and total fluid volume showed no differences in outcomes. While there was a non-significant trend suggesting potential benefit of balanced fluids in the most severely ill patients, the study was not powered to confirm this finding.

Major Findings

The results of PRoMPT BOLUS can be distilled into several key conclusions:

  • Both 0.9% saline and balanced fluids are safe and effective for treatment of children with suspected septic shock
  • Fluid type does not influence major clinical outcomes, including mortality or kidney injury
  • Biochemical differences exist between fluid choices, but did not translate to differences in clinical outcomes

Importantly, while the study cannot fully exclude a benefit of balanced fluids in the sickest patients, it provides strong evidence that for children presenting to the ED with suspected sepsis, either fluid is an appropriate choice.

Clinical Implications

These findings have immediate and meaningful implications for clinical practice.

First, they simplify decision-making. Clinicians can focus on timely recognition and treatment of children with suspected sepsis, and engage in fluid resuscitation with fluids that make sense for the clinical scenario.

Second, the results support flexibility in care. Fluid choice can now be guided by:

  • Availability
  • Medication compatibility
  • Patient-specific factors (e.g., electrolyte abnormalities, underlying conditions)

Limitations

While the study is robust, several limitations should be considered.

The overall incidence of MAKE30 was lower than expected (~3% vs. an anticipated ~6%), which may reflect a less severely ill population than initially projected. This could limit the ability to detect small differences between groups.

Additionally, although subgroup analyses suggested a possible benefit of balanced fluids in more severely ill patients, the study was not powered to draw definitive conclusions in this population.

Bottom Line

The PRoMPT BOLUS trial provides the strongest evidence to date addressing fluid choice in children presenting to the ED with suspected sepsis. Both 0.9% saline and balanced crystalloids are safe and effective for resuscitation in children with suspected septic shock.

References

  1. Balamuth F, Weiss SL, Long E, et al; PRoMPT BOLUS Investigators of the PECARN, PERC, and PREDICT Networks. Balanced Fluid or 0.9% Saline in Children Treated for Septic Shock. N Engl J Med. Published online April 24, 2026. doi:10.1056/NEJMoa2601969
By |2026-05-04T21:19:59-07:00May 7, 2026|Critical Care/ Resus, Pediatrics|

Who Gets Mistriaged? Disparities in Pediatric Behavioral Health ED Triage | A PECARN multicenter analysis

mistriaging of pediatric mental health conditions with ESI
A 14-year-old Hispanic girl presents to the Emergency Department with her mother for suicidal ideation after a conflict at home. The girl is quiet and cooperative. Her mother, who speaks primarily Spanish, is trying to explain the situation. The nurse assigns an ESI level 2, the same score given to nearly every child who walks through the door with a behavioral health complaint. But does that score accurately capture this patient’s needs?

A new multicenter PECARN study published this week in JAMA Network Open takes a close look at triage accuracy for pediatric behavioral health ED visits. The findings: mistriaging errors are common, and they are not equally distributed [1].

Hoffmann et al. analyzed 78,411 ED visits by children aged 5 to 17 with behavioral health chief concerns across 15 PECARN Registry EDs from 2021 to 2023 [1]. They classified each visit as appropriately triaged, overtriaged, or undertriaged using vital signs, Glasgow Coma Scale, pain scores, emergency medication use, resource utilization, and disposition. Of the 74,564 visits with complete data:

  • 57% were overtriaged
  • 34% were appropriately triaged
  • 8.5% were undertriaged

How ESI Handles Behavioral Health

The Emergency Severity Index (ESI) is used in over 90% of US EDs [2]. It sorts patients into 5 acuity levels. Level 1 is for patients needing lifesaving interventions. Level 2 is for high-risk situations, confused patients, or those in severe pain. Levels 3 through 5 are based on anticipated resource needs. In this study, 83.5% of all behavioral health visits were triaged as ESI level 2.

To assess triage accuracy, the authors compared each child’s assigned ESI level against what actually happened during their visit.

Overtriage

Overtriage means a child was assigned a higher acuity score than their clinical course supported. For a child assigned ESI level 2, overtriage was defined as meeting ALL of the following [1]:

  • Stable vital signs within 2 hours of arrival (heart rate and respiratory rate not high risk for age, SpO2 ≥93% or not recorded)
  • Pain score <7 (or not recorded)
  • GCS of 15 (or not recorded)
  • No emergency medications during the visit

In other words, the triage nurse predicted high acuity, but the visit didn’t bear that out.

Undertriage

Undertriage means the opposite: a child was assigned a lower acuity score than their clinical course warranted. For example, a child triaged as ESI level 4 (expected to need 1 resource) who ended up being admitted, needing emergency medications, or using multiple resources. The triage nurse underestimated how sick the child was or how much care they would need.

Undertriage Disproportionately Affects Minority Children and Spanish-Speaking Families

The most concerning equity finding was in undertriage.

After adjusting for clinical and visit characteristics, undertriage was significantly more likely for Hispanic children (AOR 1.46), non-Hispanic Black children (AOR 1.28), and children whose families preferred Spanish (AOR 1.31), all compared to non-Hispanic White and English-speaking patients [1]. The authors point to implicit clinician bias, systemic racism, and underutilization of professional interpreters as likely contributors.

The safety implications are real. Children whose acuity is underestimated may face longer waits, miss time-sensitive interventions, or leave the ED without being seen despite elevated risk.

Overtriage Was Common

More than half of all visits (57%) were overtriaged [1]. These children received a higher acuity triage score than their clinical course supported.

The strongest predictor was age. Children aged 5-9 had over 4-fold higher adjusted odds of overtriage compared to those aged 10-14 (AOR 4.43), possibly because younger children have a limited ability to communicate their symptoms and needs.

To a lesser degree, non-Hispanic Black children also had higher adjusted odds of overtriage compared to non-Hispanic White children (AOR 1.17). The authors cite research on adultification, the tendency to perceive Black youth as older or more threatening than they are, as a potential contributor. This means Black children in this study were more likely to be both undertriaged and overtriaged compared to White children. The errors are not unidirectional. They likely reflect different biases operating at different points in care.

Take Home Points

  1. The ESI has limited ability to differentiate pediatric behavioral health presentations. In this study, 83.5% of behavioral health visits were triaged as ESI level 2.
  2. UNDERTRIAGE was more likely for Hispanic children (AOR 1.46), non-Hispanic Black children (AOR 1.28), and Spanish-speaking families (AOR 1.31), raising concerns about missed acuity in these groups.
  3. OVERTRIAGE occurred in 57% of visits, driven most strongly by younger age (AOR 4.43 for ages 5 to 9) and to a lesser degree by non-Hispanic Black race (AOR 1.17).

References

  1. Hoffmann JA, Foster AA, Rojas CR, et al. Overtriage and undertriage of children presenting to the emergency department for behavioral health. JAMA Netw Open. 2026;9(3):e263042. Full text
  2. McHugh M, Tanabe P, McClelland M, Khare RK. More patients are triaged using the Emergency Severity Index than any other triage acuity system in the United States. Acad Emerg Med. 2012;19(1):106-109. doi:10.1111/j.1553-2712.2011.01240.x
By |2026-03-28T19:43:20-07:00Mar 28, 2026|Pediatrics, Psychiatry|

From Collision to Clarity: PECARN cervical spine injury prediction rule for injured children

PECARN cervical spine injury prediction tool featured image (adapted from Midjourney)

For years, adult literature has provided clear guidelines for cervical spine imaging through the NEXUS and Canadian C-spine Rule (CCR) tools. These have been invaluable in helping clinicians decide when to image the neck in trauma patients. Similarly, the Pediatric Emergency Care Applied Research Network (PECARN) has developed robust tools for assessing blunt head trauma in children. However, until now, there has been a gap in guidance for clinicians managing pediatric patients at risk for cervical spine injuries.

Case Scenario: What would you do?

A 10-year-old boy presents to the emergency department (ED) after a high-speed motor vehicle collision. He complains of neck pain and is reluctant to move his head. The child’s mother is extremely worried, fearing the worst after witnessing the collision.

The Problem

Cervical spine injuries in children, while uncommon, can be devastating if not identified and treated promptly. Emergency physicians often face the challenge of deciding whether to proceed with imaging, given the potential risks associated with ionizing radiation from CT scans. The lack of clear guidelines specifically tailored for pediatric patients has historically led to either overuse of imaging, with its associated risks, or underuse, with the risk of missed injuries.

PECARN Cervical Spine Injury Prediction Rule

On June 4, 2024, Lancet published “PECARN prediction rule for cervical spine imaging of children presenting to the emergency department with blunt trauma: a multicentre prospective observational study.” This study proposes a new clinical prediction rule to guide imaging decisions for pediatric cervical spine injuries.

The study enrolled 22,430 children, aged 0–17 years, presenting with blunt trauma across 18 PECARN-affiliated ED in the US. About half were in the derivation and half in the validation cohort. The researchers derived and validated a clinical prediction rule using data from these children, which identified key risk factors for cervical spine injury, divided into high-risk and non-negligible (intermediate) risk factors.

High Risk (>12.1% risk of injury) -> Consider CT

  • Altered mental status (GCS 3-8 or AVPU = U)
  • Abnormal airway
  • Breathing
  • Circulation findings
  • Focal neurological deficits

Intermediate Risk (2.8% risk of injury) -> Consider X-Rays

  • Neck pain or midline neck tenderness
  • Mental status: GCS 9-14, AVPU = V or P, or other signs of altered mental status
  • Substantial head or torso injury

Definition on Cervical Spine Injury

  • Fractures or ligamentous injuries of the cervical spine
  • Cervical intraspinal hemorrhage
  • Cerebral artery injury
  • Cervical spinal cord injury, including
    • Changes in the cervical spinal cord on MRI
    • Cervical spinal cord injury without radiographic association
PECARN Cervical Spine Injury Prediction Tool

PECARN Cervical Spine Injury Prediction Tool (Download full sized PDF at PECARN site)

The prediction rule had strong test characteristics with 94.3% sensitivity and 99.9% negative predictive value, indicating that it can reliably identify children who do not need imaging, thus avoiding unnecessary radiation exposure. This evidence-based approach to pediatric trauma care would have reduced the number of CT scans by more than 50% without missing clinically relevant injuries.

Case Example Resolution

Using the PECARN cervical spine injury prediction rule, the attending physician evaluates the boy and finds that he does not exhibit any high-risk factors. However, because he reports neck pain and has midline neck tenderness on exam (intermediate risk), the rule recommends that the cervical spine can not be clinically cleared. It also suggests plain x-rays and not a CT scan. This differs from the adult population whereby CT scan imaging is often the first choice for diagnostic testing.

The x-rays reveal no evidence of cervical spine injury, and the boy is cleared with instructions for follow-up care. This approach not only alleviated the mother’s anxiety but also avoided unnecessary radiation exposure for the child.

Reference

Leonard JC, Harding M, Cook LJ, et al. PECARN prediction rule for cervical spine imaging of children presenting to the emergency department with blunt trauma: a multicentre prospective observational study. Lancet Child Adolesc Health. 2024;8(7):482-490. doi:10.1016/S2352-4642(24)00104-4. PMID 38843852

By |2026-01-08T21:25:20-08:00Jun 10, 2024|Pediatrics, Radiology, Trauma|

Computerized Adaptive Screen for Suicidal Youth (CASSY) study

CASSY PECARN suicide screening tool

Adolescent suicide rates in the United States, partly augmented by the COVID-19 pandemic, are steadily increasing [1, 2]. A commonly used screening tool is the 4-question Ask Suicide-Screening Questions (ASQ) instrument, which has a sensitivity and specificity of 60% and 92.7%, respectively, in predicting suicide-related events within 3 months. This was derived from a retrospective study of 15,003 pediatric patients (age 10-18 years) [3]. Given the morbidity and mortality associated with suicide attempts, is there a better screening tool with a higher sensitivity than 60%, while also maintaining adequate specificity? A higher sensitivity rate ensures that we have fewer misses.

The CASSY tool

In JAMA Psychiatry 2021, the Pediatric Emergency Care Applied Research Network (PECARN) researchers report derivation and external validation data for their suicide screening tool, called the Computerized Adaptive Screen for Suicidal Youth (CASSY) [4]. This publication was actually two studies in one: a derivation of the tool and then an external validation.

Terminology

This paper assumes that the reader understands certain predictive analytics methodologies and test design concepts. Let’s briefly review some of the foundational terminology used:

  • Item response theory [Wikipedia]: “It is a theory of testing based on the relationship between individuals’ performances on a test item and the test takers’ levels of performance on an overall measure of the ability that item was designed to measure.” Of note, each item may be weighted differently based on how well it correlates with the overall outcome measure, which in this study was suicide attempt within 3 months.
  • Computerized adaptive testing [Wikipedia]: This computer testing strategy, also known as tailored testing, presents questions based on the individual’s response to a prior question.
  • Receiver operator characteristics (ROC): “The performance of a diagnostic test in the case of a binary predictor can be evaluated using the measures of sensitivity and specificity. However, in many instances, we encounter predictors that are measured on a continuous or ordinal scale. In such cases, it is desirable to assess performance of a diagnostic test over the range of possible cutpoints for the predictor variable. This is achieved by a receiver operating characteristic (ROC) curve that includes all the possible decision thresholds from a diagnostic test result.” [5] In other words, test sensitivities can be calculated for set specificities of, for instance, 70%, 80%, and 90%. Based on the purpose of the diagnostic test, the binary predictor threshold would be set accordingly.
  • Area under the curve (AUC): Calculating the AUC for the ROC is an effective means to determine a diagnostic test’s accuracy. The AUC ranges from 0 to 1 with 0.5 meaning no discrimination (i.e., the test can not diagnose patients with and without the disease based on the test). Generally, an AUC value of 0.7-0.8 is acceptable, 0.8 to 0.9 is excellent, and >0.9 is outstanding [5].

Study 1: CASSY derivation

A total of 6,536 adolescents (age 12-17 years) from 13 PECARN emergency departments were enrolled and a subset were randomly received follow-up in 3 months to assess for a suicide attempt. These patients responded to 92 questions on a computer tablet. Using a multidimensional item response theory approach, the more correlated questions (72) were used to create the CASSY tool.

Test characteristic results:

  • AUC: 0.89 (excellent)
  • Using the ROC curve, the CASSY sensitivity was 83% and 61% for the fixed specificity of 80% and 90%, respectively.

Study 2: CASSY validation

A total of 4,050 adolescents from 14 PECARN emergency departments were enrolled, and all received 3-month follow-up assessing for a suicide attempt. These patients completed the CASSY tool, as well as a subset of questions from study 1 for comparison. The frequency of questions used in the adaptive screen are itemized in the paper.

Test characteristic results:

  • AUC 0.87 (excellent)
  • Using the ROC curve and at the 80% specificity cutoff from study 1, the CASSY sensitivity was 82.4% and specificity was 72.5%.

CASSY figure ROC

Limitations

Although there was strong study rigor by deriving and independently validating the tool in separate, multicenter populations, it should be noted that generalizability may be affected.

  1. The study was conducted in academic pediatric emergency departments.
  2. There was quite a few patients who were lost to follow up (27.1% in study 1, 30.5% in study 2), which may have skewed the results.
  3. Selection bias may have occurred because of patients declining to participate in the study (62% enrollment rate in study 1, 62.2% in study 2)

Bottom line

The CASSY tool accurately serves as a screening predictive tool for adolescents at risk for a suicide attempt in 3 months. Rather than having patients complete exhaustively long (and practically unfeasible) screening questions in the emergency department, this computerized adaptive tool required only a mean of 11 questions, which took a median time of 1.4 minutes (IQR 0.98-2.06 minutes) to complete.

How can you implement CASSY in your emergency department?

We asked the authors this question, and the answer is in the podcast below.

Podcast

Listen more with author Dr. Jacqueline Grupp-Phelan talking with ALiEM podcast host, Dr. Dina Wallin, about this landmark paper and behind-the-scenes issues not included on the paper.

This blog post was expert peer-reviewed by Drs. King and Grupp-Phelan, who authored the paper.

References

  1. Hill RM, Rufino K, Kurian S, Saxena J, Saxena K, Williams L. Suicide Ideation and Attempts in a Pediatric Emergency Department Before and During COVID-19 [published online ahead of print, 2020 Dec 16]. Pediatrics. 2020;e2020029280. PMID: 33328339
  2. Centers for Disease Control and Prevention. Web-based Injury Statistics Query and Reporting System (WISQARS). Published 2020.
  3. DeVylder JE,Ryan TC, Cwik M, et al. Assessment of selective and universal screening for suicide risk in a pediatric emergency department. JAMA Netw Open. 2019;2(10):e1914070-e1914070. PMID 31651971
  4. King CA, Brent D, Grupp-Phelan J, et al. Prospective Development and Validation of the Computerized Adaptive Screen for Suicidal Youth [published online ahead of print, 2021 Feb 3]. JAMA Psychiatry. 2021; 10.1001/jamapsychiatry.2020.4576. doi:10.1001/jamapsychiatry.2020.4576. PMID 33533908
  5. Mandrekar JN. Receiver operating characteristic curve in diagnostic test assessment. J Thorac Oncol. 2010;5(9):1315-1316. doi:10.1097/JTO. 0b013e3181ec173d

Listen to all the PECARN podcasts

PECARN: Its relevance and importance in pediatric emergency care

PECARNDid you know that many of the landmark pediatric emergency medicine (EM) studies come from the Pediatric Emergency Care Applied Research Network (PECARN) collaborative? It works to address the challenging pediatric questions that only multicenter studies can. In this blog post, we highlight PECARN’s goal to translate, disseminate, and implement evidence to all providers of emergent and urgent care for pediatric patients.

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By |2020-05-01T15:32:49-07:00Jan 7, 2020|Pediatrics|

PECARN Study: Accuracy of Urinalysis for Febrile Infants ≤60 Days Old

The reported accuracy of the urinalysis (UA) for diagnosing urinary tract infections (UTI) is febrile infants ≤ 60 days has been widely variable. Some guidelines specifically exclude these patients due to this variability or recommend urine culture as the primary test.1

Accuracy of the Urinalysis for Urinary Tract Infections in Febrile Infants 60 Days and Younger, published in Pediatrics in February of 2018, addressed this topic head-on.2 The authors sought to evaluate the accuracy of the UA by analyzing data in a planned secondary analysis of a prospectively collected data set, as part of the Pediatric Emergency Care Applied Research Network (PECARN). We review this publication and present a behind-the-scenes podcast interview with lead author Dr. Leah Tzimenatos.
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By |2021-07-01T21:07:41-07:00Sep 27, 2018|Infectious Disease, Pediatrics|

PECARN Pediatric Head Trauma: Official Visual Decision Aid for Clinicians

pecarn pediatric head traumaThe Pediatric Emergency Care Applied Research Network (PECARN) collaborative has teamed up with the ALiEM and CanadiEM teams to introduce the official PECARN visual decision rule aid for pediatric blunt head trauma! This has been a 6 month collaboration focused on bringing evidence-based research to the bedside in pediatric emergency medicine (EM).

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By |2024-06-01T10:49:21-07:00Jun 27, 2017|Pediatrics, Trauma|
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