Life After Pediatric Sepsis Evaluation
Status: | Not yet recruiting |
---|---|
Conditions: | Hospital |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | Any - 18 |
Updated: | 5/27/2013 |
Start Date: | June 2013 |
End Date: | June 2018 |
Contact: | Jerry J. Zimmerman, MD, PhD |
Email: | jerry.zimmerman@seattlechildrens.org |
Phone: | 206-987-3862 |
Sepsis represents the leading cause of childhood mortality worldwide. However, as distinct
from adult medicine, there exists a large knowledge gap regarding long term health related
quality of life (HRQL) and functional status (FS) following pediatric sepsis. This lack of
sepsis outcomes data is critical because failure to identify children at risk for sepsis
associated HRQL/FS deterioration may delay delivery of crucial rehabilitation medicine
efforts to facilitate recovery. Moreover, failure to identify mechanisms of sepsis
associated HRQL/FS deterioration may impede development of novel, effective interventions
for these children. For the first time the LAPSE investigation will quantify deterioration
of HRQL/FS among children surviving sepsis. We will measure the incidence, magnitude and
duration of HRQL/FS alterations associated with pediatric septic shock, and examine
clinical, sociodemographic, and parent/family factors potentially associated with such
adverse outcomes. Because sepsis affects a heterogeneous group of children, long term
morbidity associated with sepsis likely depends on premorbid health status and parent,
family and home characteristics, as well as children's clinical course during sepsis
critical illness. Mechanisms underlying adverse sepsis outcomes among children are poorly
understood at this time. Clinically multiple organ dysfunction syndrome (MODS)has been
clearly linked to sepsis mortality. To begin to understand pathophysiology underlying
pediatric sepsis morbidity, this investigation will seek to identify evidence for
association of HRQL/FS alterations following sepsis with intensity and duration of sepsis
mediated organ dysfunction as well as with pre-existing comorbidities and parent, family,
and home characteristics. Thelong term goal of this research program is to timely identify
children at high risk of sepsis mediated HRQL/FS deterioration and ultimately to design
effective interventions to minimize such risk. The primary objectives of this investigation
are to comprehensively characterize HRQL/FS trajectory and to critically examine the
potential role of sepsis mediated organ dysfunction as well as pre-existing comorbidities
and parent, family,and home characteristics as risk factors for the adverse outcomes. The
central hypothesis is that intensity of sepsis organ dysfunction will predict magnitude of
HRQL/FS deterioration. We also hypothesize that the trajectory towards baseline HRQL/FS
following the sepsis event will also depend on pre-existing co-morbidities and parent,
family, and home, and characteristics. Knowledge of these potential mechanisms will
ultimately facilitate development of targeted interventions to maximize HRQL/FS among
children surviving sepsis.
Inclusion Criteria:
- Age 44 weeks EGA to 18 years
- Admitted to the PICU for the sepsis event
- Evidence of SIRS including fever/ hypothermia and leukocytosis/leukopenia
- Documented or suspected infection
- Cardiovascular organ dysfunction with need for vasoactive-inotropic support
Exclusion Criteria:
- Lack of commitment to aggressive sepsis therapy OR
- Ward of the state OR
- Sepsis event associated with a PICU-acquired nosocomial infection OR
- Parents do not speak English or Spanish OR
- Previously enrolled in the LAPSE study
- Enrollment not possible within 12 hours of PICU admission
We found this trial at
11
sites
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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University of Utah Research is a major component in the life of the U benefiting...
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Children's Hospital of Michigan Since 1886, the Children's Hospital of Michigan has been dedicated to...
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Phoenix Children's Hospital Phoenix Children's Hospital has provided hope, healing, and the best healthcare for...
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Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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