Adjunctive Therapies in Pediatric Severe Sepsis and Septic Shock: An Analysis through Multi-Center Linkage of the Virtual Pediatric Systems and PEDSnet
Study Dates
Last Modified
Tags
Publisher
Abstract
Study to measure variations in resource utilization across centers, determine the association of adjuvant therapies with mortality, and detect the presence of multiple organ disfunction syndrome (MODS) in children with severe sepsis or septic shock through the creation of a linked multicenter dataset.
Affiliation(s)
Funder(s)
Provenance
Description
Pediatric severe sepsis, an overwhelming systemic inflammatory response to infection, is a leading cause of mortality in pediatric intensive care units (PICUs) worldwide. Despite decades of sepsis research, the main therapies available for the management of sepsis essentially remain goal-directed fluid resuscitation, timely antibiotic administration, and supportive care for organ dysfunction. Additional adjunctive therapies including blood product transfusions, plasmapheresis, and extracorporeal membranous oxygenation (ECMO) are often administered empirically in patients with sepsis and multiple organ dysfunction syndrome (MODS). While these are important adjuncts in the management of critically ill patients, the efficacy of such therapies and the conditions under which their use may be warranted remain unknown and controversial. Multi-institution randomized trials require large numbers of patients, have high costs and take long periods of time. Retrospective analysis of multi-institution databases of pediatric critical care patients offer a valuable tool to assist researchers in describing resource utilization and comparing intervention effectiveness across the population. However a critical gap exists in the lack of a comprehensive multi-institution dataset which: (a) accurately identifies patients with severe sepsis and septic shock, (b) includes comprehensive measurements and results sufficient to stratify patients and detect MODS, and © provides longitudinal resource utilization data.
To address this problem, two, large, multi-center databases of ICU care address the above knowledge gap. Linkage is accomplished using probabilistic algorithms which match similarly to human pattern recognition and do not rely on common identifiers. The objectives of this study are to measure variations in resource utilization across centers, determine the association of adjuvant therapies with mortality, and detect the presence of MODS in children with severe sepsis or septic shock through the creation of a linked multicenter dataset.
Hypothesis
Substantial variations in resource utilization exist in the management of severe sepsis and septic shock after adjusting for patient-level covariates. Identification of these variations will allow for novel investigations of the comparative effectiveness of such therapies.
Specific Aims
- Create a combined, multicenter dataset through linkage of the VPS and PEDSnet datasets and describe the characteristics of this dataset with respect to patients, diagnoses and outcomes. This dataset will include six years of data at the eight academic pediatrics institutions in the PEDSnet dataset.
- Measure and compare resource utilization of key interventions and adjunctive therapies across centers in patients with severe sepsis and septic shock, including: vasoactive medications, invasive and non-invasive ventilation, inhaled nitric oxide, blood product transfusions, plasmapheresis, hemodialysis and ECMO. Determine the associations of these interventions with outcomes of mortality and ICU-free days in models adjusted for age, sex and illness severity.
- Evaluate the capability to detect MODS in patients with severe sepsis and septic shock on day 7 and day 28 using standard diagnostic criteria. Develop and validate a supervised classification algorithm to identify the presence of MODS in our multicenter cohort at day 7 and 28 after onset of severe sepsis and septic shock.
Development Code
Vocabulary
Clinical Subjects Headings
Creative Commons license
