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Implementation Trial of Predictive Modeling to Enhance Diagnosis and Improve Treatment in Pediatric Septic Shock
N/A
Waitlist Available
Led By Halden F Scott, MD, MSCS
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 hours after emergency department arrival
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a computer tool that helps doctors identify children at risk of severe infection early. It targets children in emergency rooms who might have sepsis. The tool uses hospital data to warn doctors early about high-risk cases, aiming to improve timely treatment and outcomes.
Eligible Conditions
- Emergency
- Sepsis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 hours after emergency department arrival
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 hours after emergency department arrival
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Patients Receiving Guideline-Concordant Septic Shock Care
Secondary study objectives
Time to Antibiotics
Other study objectives
30-Day In-Hospital Mortality
Number of Patients Receiving Intravenous Antibiotics during Emergency Department care
Number of Patients With Septic Shock
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Septic Shock Clinical Decision SupportExperimental Treatment1 Intervention
Emergency Department sites in this arm will have Clinical Decision Support (CDS) alerts active in the Electronic Health Record during clinical ED care of patients with suspected sepsis, in addition to following usual institutional standard of care for sepsis. The CDS will alert providers to patients at high risk for developing septic shock.
Group II: Clinical Diagnosis OnlyActive Control1 Intervention
Emergency Department sites in this arm will follow the institutional standard for sepsis care without Clinical Decision Support. Standard care includes clinical diagnosis of sepsis supported by institutional sepsis education, a sepsis pathway and orderset.
Find a Location
Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,809 Previous Clinical Trials
2,820,954 Total Patients Enrolled
Agency for Healthcare Research and Quality (AHRQ)FED
406 Previous Clinical Trials
6,755,866 Total Patients Enrolled
Halden F Scott, MD, MSCSPrincipal InvestigatorUniversity of Colorado, Denver