Pediatric Sepsis Program Research Overview

PRoMPT BOLUS is a multi-center, open-label, pragmatic interventional trial in which children with suspected septic shock are randomized to receive either 0.9% saline or balanced/buffered crystalloid fluids for initial resuscitation, followed by maintenance fluids in addition to usual care.

All patients over 6 months to under 18 years treated for suspected septic shock with parenteral antibodies and at least one fluid bolus for abnormal perfusion in a study site emergency department are eligible for study enrollment. Prospective written informed consent will be sought from a legally authorized representative prior to enrollment when sufficient time permits; however, due to the life-threatening nature of septic shock and narrow therapeutic window to commence fluid resuscitation, enrollment may proceed in the United States under the Exception from Informed Consent Requirements for Emergency Research, and in Canada, Australia, and New Zealand with deferred consent in compliance with the Canadian Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans and National Statement on Ethical Conduct in Human Research, respectively.

In partnership with the Division of Neonatology and the Department of Biomedical and Health Informatics, Pediatric Sepsis Program (PSP) uses informatics tools and the electronic health record to develop novel clinical decision making support tools and improve early recognition of sepsis among critically ill infants in the neonatal intensive care unit.

Sepsis in infants is associated with significant morbidity and mortality, yet recognition remains difficult given its heterogeneous presentation in infants with complex medical conditions and comorbidities. Previous prediction models have had limited effectiveness in busy clinical settings as they do not reflect the clinical context or support comprehension of the continually evolving state of critically ill patients.

Based on preliminary work in predictive modeling and existing data from our neonatal sepsis registry, the PSP is well positioned to develop novel methods to improve sepsis identification in critically ill infants. In the first phase of the project, the research team is refining predictive model outputs that will be paired with displays of clinical information to improve clinician recognition of sepsis. In the second phase, and in collaboration with experts from the Center for Simulation, Advanced Education and Innovation at CHOP, the team will test the prototype system with clinicians and nurses to measure its effectiveness in improving sepsis recognition.

Future goals include developing a prospective clinical trial to examine this early sepsis recognition prototype and providing clinicians and nurses with the decision support to improve the health and well-being of critically ill infants at the highest risk of sepsis.

The CHOP Sepsis Registry was originally inspired by the Epidemiologic Surveillance Definition of Pediatric Sepsis developed by the Pediatric Sepsis Program in collaboration with Arcus. This registry is housed in Arcus and is an active institutional resource for those looking to conduct clinical research at CHOP. Access to this tool is available to CHOP staff via an electronic request form, and is maintained by PSP data staff. PSP leadership will review all requests and will follow-up with specifics around a timeline and data use guidelines.