Clinical Trials Logo

Clinical Trial Summary

This study is a prospective, stepped-wedge implementation trial to test the effects of implementing a Clinical Decision Support (CDS) tool for prediction of septic shock in four Emergency Departments within a pediatric healthcare network. The primary outcome will be the proportion of sepsis patients who receive guideline-concordant septic shock care after implementation of the CDS, and the secondary outcome will be time-to-antibiotic after sepsis recognition.


Clinical Trial Description

Septic shock is a leading global cause of pediatric death. In the US, the in-hospital mortality rate for children with sepsis is 5-20%. Septic shock is a state of critical infection that requires advanced and resource-intensive resuscitation, and morbidity-free survival depends on timely diagnosis. Critical care delivered in a delayed fashion, after a child is in hypotensive shock, is less effective; for each hour of unrecognized shock the odds of death more than double. Advances have been made in timely sepsis treatment, but improving diagnosis of septic shock in children remains elusive. Improved early diagnosis would accelerate treatment and improve outcomes. Tools that have been deployed to improve diagnosis in pediatric sepsis either diagnose it after organ dysfunction criteria have been met, or depend heavily on subspecialty physician judgment and have not been tested outside of tertiary pediatric hospitals. Thus, the evidence-based 2020 Surviving Sepsis Children's Guidelines for pediatric sepsis stated that "high-quality trials on pediatric sepsis recognition are lacking, and data are not sufficient to suggest any particular screening tool," and identified pediatric sepsis recognition trials as an important research need. Despite this, the guidelines weakly recommended screening patients "who present as acutely unwell" for septic shock, citing very low quality evidence. The guidelines also stated that there is no evidence for the effectiveness of any existing pediatric sepsis screening tools. This study addresses the gap in knowledge about the effectiveness of pediatric sepsis prediction tools. The study team has developed and retrospectively validated early diagnostic models that leverage clinical data in the Electronic Health Record (EHR) to predict septic shock in children the emergency setting [1, 2]. In order to address concerns about alert fatigue and antibiotic overuse, these predictive models were designed to identify patients at high risk for shock among patients in whom clinicians initially had some suspicion for sepsis. In this pilot implementation trial, Clinical Decision Support based on septic shock prediction models will be introduced to 4 pediatric Emergency Departments (EDs) within the Children's Hospital Colorado care system in a stepped wedge design, in addition to routine clinical care. Routine clinical care at all study sites includes existing sepsis pathways, order sets, and quality metrics that are aligned with the national Improving Pediatric Sepsis Outcomes Collaborative and the Pediatric Surviving Sepsis guidelines. The primary outcome will be the proportion of sepsis patients who receive guideline-concordant septic shock care after implementation of the CDS, and the secondary outcome will be time-to-antibiotic after sepsis recognition. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05065333
Study type Interventional
Source University of Colorado, Denver
Contact Halden F Scott, MD, MSCS
Phone 303-724-2601
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date November 30, 2021
Completion date November 30, 2022

See also
  Status Clinical Trial Phase
Completed NCT02714595 - Study of Cefiderocol (S-649266) or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens Phase 3
Completed NCT03644030 - Phase Angle, Lean Body Mass Index and Tissue Edema and Immediate Outcome of Cardiac Surgery Patients
Terminated NCT04117568 - The Role of Emergency Neutrophils and Glycans in Postoperative and Septic Patients
Recruiting NCT03550794 - Thiamine as a Renal Protective Agent in Septic Shock Phase 2
Active, not recruiting NCT04332861 - Evaluation of Infection in Obstructing Urolithiasis
Completed NCT04227652 - Control of Fever in Septic Patients N/A
Enrolling by invitation NCT05052203 - Researching the Effects of Sepsis on Quality Of Life, Vitality, Epigenome and Gene Expression During RecoverY From Sepsis
Terminated NCT03335124 - The Effect of Vitamin C, Thiamine and Hydrocortisone on Clinical Course and Outcome in Patients With Severe Sepsis and Septic Shock Phase 4
Completed NCT03258684 - Hydrocortisone, Vitamin C, and Thiamine for the Treatment of Sepsis and Septic Shock N/A
Recruiting NCT05018546 - Safety and Efficacy of Different Irrigation System in Retrograde Intrarenal Surgery N/A
Completed NCT03295825 - Heparin Binding Protein in Early Sepsis Diagnosis N/A
Not yet recruiting NCT04870125 - Safety Study of Inhaled Carbon Monoxide to Treat Sepsis-Induced Acute Respiratory Distress Syndrome (ARDS) Phase 1
Recruiting NCT05036928 - Study of MDW Levels Predicting the Development of Sepsis in Hospitalized HIV-infected Patients and Correlation With Prognosis
Not yet recruiting NCT04291508 - Acetaminophen and Ascorbate in Sepsis: Targeted Therapy to Enhance Recovery Phase 2
Not yet recruiting NCT05033808 - Epirubicin for the Treatment of Sepsis & Septic Shock Phase 2
Not yet recruiting NCT04516395 - Optimizing Antibiotic Dosing Regimens for the Treatment of Infection Caused by Carbapenem Resistant Enterobacteriaceae N/A
Recruiting NCT02922998 - CD64 and Antibiotics in Human Sepsis N/A
Recruiting NCT02930070 - qSOFA in General Wards: the Accuracy in Diagnosis of Sepsis N/A
Recruiting NCT02899143 - Short-course Antimicrobial Therapy in Sepsis Phase 2
Completed NCT02907931 - Carotid Doppler Ultrasound for the Measurement of Intravascular Volume Status N/A