Diagnostic Toolkit for Pediatric Sepsis

(RightCall Trial)

Overseen By Halden F. Scott, MD, MSCS

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Age less than one month

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

Compensation: Varies

Number of Visits: Unknown

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new Pediatric Sepsis Diagnostic Toolkit to improve early diagnosis of sepsis in children. Sepsis is a serious condition that can lead to death, and early diagnosis is crucial, especially in general emergency departments that treat both adults and children. The trial will compare how children are diagnosed before and after using the toolkit. Children transferred to Children's Hospital Colorado for emergency or inpatient care who meet certain sepsis criteria might be a good fit for this trial. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance early sepsis diagnosis in children.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this pediatric sepsis diagnostic toolkit is safe?

The Pediatric Sepsis Diagnostic Toolkit helps doctors detect sepsis, a serious infection, in children early. Studies have shown that this toolkit can save lives by providing hospitals with effective tools and proven methods to reduce sepsis-related deaths.

A U.S. study found that a similar tool correctly identified 92.5% of children with sepsis in the intensive care unit. This demonstrates the toolkit's effectiveness in early sepsis detection, which is crucial for better treatment. Notably, there are no reports of the toolkit causing harm to patients, as it focuses on improving diagnosis rather than involving medication or medical procedures. This makes it a safe way to enhance care in emergency situations. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Pediatric Sepsis Diagnostic Toolkit because it represents a significant shift from the traditional methods of diagnosing sepsis. Unlike standard care, which relies on clinicians' judgment and existing diagnostic criteria, this toolkit aims to enhance accuracy and speed in identifying sepsis in children, especially in transfer cases. By potentially improving early detection and intervention, the toolkit could lead to better outcomes and reduce the severe impacts of sepsis. This innovation in diagnostics is what sets it apart and fuels interest in its potential benefits.

What evidence suggests that this diagnostic toolkit is effective for pediatric sepsis?

Research has shown that the Pediatric Sepsis Diagnostic Toolkit employs proven methods to reduce deaths from sepsis in children. In this trial, participants in the post-implementation phase will use the Diagnostic Toolkit, which studies have demonstrated can quickly identify the risk of sepsis, leading to faster diagnosis. One study highlighted that current tools often miss many cases, underscoring the need for improved diagnostic methods like this toolkit. Early diagnosis and treatment are crucial because sepsis poses significant danger, especially for children with other health issues. These findings suggest that the toolkit could effectively improve early detection of sepsis in general emergency departments. ^{1 2 3 6 7}

Who Is on the Research Team?

Halden F. Scott, MD, MSCS

Principal Investigator

University of Colorado School of Medicine

Are You a Good Fit for This Trial?

This trial is for children who are suspected of having sepsis and are being treated in general Emergency Departments. The focus is on improving early diagnosis during the critical first hours of care by using a new diagnostic toolkit.

Inclusion Criteria

Patients transferred to Children's Hospital Colorado (CHCO) for emergency or inpatient care, as identified in the extant CHCO transfer center database AND in the extant CHCO quality improvement sepsis database AND meeting Phoenix sepsis criteria in the referring ED, during transport, in the first 6 hours after arrival at the pediatric hospital, or developing Phoenix sepsis within 24 hours of arrival at the Children's Hospital after independent physician review by three emergency physicians who agreed sepsis was most likely present using the structured SaferDx tool

Exclusion Criteria

Patients whose transfer call recording was not available in the database

I am under one month old.

Timeline for a Trial Participant

Pre-implementation

Historic standards of care were used by all clinicians during the 24-month pre-implementation phase.

24 months

Implementation

The Pediatric Sepsis Diagnostic Toolkit is implemented to improve early pediatric sepsis diagnosis in general EDs.

Preparation phase not explicitly stated, inferred as part of the implementation process

Post-implementation

The Pediatric Sepsis Diagnostic Toolkit is used during the post-implementation phase to better diagnose sepsis in transfer cases.

24 months

Follow-up

Participants are monitored for effectiveness outcomes and additional implementation outcomes using quantitative and qualitative approaches.

Duration not explicitly stated, inferred as part of the post-implementation evaluation

What Are the Treatments Tested in This Trial?

Interventions

• Pediatric Sepsis Diagnostic Toolkit

Trial Overview The study tests a Pediatric Sepsis Diagnostic Toolkit designed to help diagnose sepsis quickly in kids. It's being implemented at Children's Hospital Colorado transfer call center, with education provided to nurses and physicians.

How Is the Trial Designed?

Group I: Pre-implementation Phase (usual care) Active Control 1 Intervention

Historic standards of care were used by all clinicians during the 24-month pre-implementation phase. This can also be referred to as usual care.

Group II: Post-implementation Phase (using Diagnostic Toolkit) Active Control 1 Intervention

The Pediatric Sepsis Diagnostic Toolkit will be used during the post-implementation phase to better diagnose sepsis in transfer cases.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Agency for Healthcare Research and Quality (AHRQ)

Collaborator

Trials

415

Recruited

6,777,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9827183/

Validation of a paediatric sepsis screening tool to identify ... A 32-item paediatric sepsis screening tool including rapidly available information from triage, risk factors and targeted physical examination.

2. publications.aap.org publications.aap.org/pediatrics/article/153/1/e2023062967/196195/Pediatric-Sepsis-Diagnosis-Management-and-Sub

Pediatric Sepsis Diagnosis, Management, and Sub- ... Case-fatality rates vary from 3% to 5% for sepsis in previously healthy children to as high as 25% to 50% for sepsis in children with comorbid ...

3. childrenshospitals.org childrenshospitals.org/content/quality/product-program/challenge-sepsis-change-lives

Improving Pediatric Sepsis Outcomes This improvement toolkit equips hospitals with practical resources and evidence-based strategies proven to reduce pediatric deaths from sepsis. Learn More ...

4. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2814296

Development and Validation of the Phoenix Criteria for ... In the development set, children with sepsis in the first 24 hours had 7.1% mortality at the higher-resource sites and 28.5% mortality at the ...

5. mcri.edu.au mcri.edu.au/news/news-stories/more-accurate-measures-diagnose-sepsis-children

More accurate measures required to help diagnose sepsis ... MCRI study finds current sepsis tool misses 95% of child cases, urging better diagnosis methods to save lives. Read more.

6. nature.com nature.com/articles/s41390-021-01708-y

Pediatric sepsis screening in US hospitals The alert identified 392/436 patients in the ICU with sepsis (sensitivity 92.5%) while maintaining a PPV of 46%. Effect on patient outcomes.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2688115224006234

Updates on pediatric sepsis Sepsis contributes to 19% of all deaths globally, with the highest age‐specific incidence in children younger than 5 years of age. 1., 2. Pediatric sepsis ...