Life After Pediatric Sepsis Evaluation
Condition: Septic Shock
MeSH terms: Sepsis
Study type: Observational

Summary: 
      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. The long-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.
    

Detailed description: 
      In-hospital pediatric sepsis mortality has decreased substantially, but long-term mortality
      and morbidity among children initially surviving sepsis, is unknown. Accordingly, the Life
      After Pediatric Sepsis Evaluation investigation was conducted to describe the trajectory of
      mortality and health-related quality of life morbidity and critical illness factors
      associated with these outcomes for children encountering community-acquired septic shock.

      Design: Prospective, cohort-outcome study, conducted 2013-2017. Setting: Twelve academic
      pediatric intensive care units (PICUs) in the United States.

      Patients: Critically ill children, 1 month to 18 years, with community-acquired septic shock
      requiring vasoactive-inotropic support. Interventions: Demographic, infection, and illness
      severity data were collected at PICU admission. Organ dysfunction and resource utilization
      data were collected during PICU stay. Serial parent proxy-report health-related quality of
      life assessments were obtained at baseline, 7 days, and 1, 3, 6, and 12 months following PICU
      admission utilizing the Pediatric Quality of Life Inventory or Stein-Jessop Functional Status
      Scale.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children aged 0-18 admitted to a PICU for septic shock
      
Keywords: sepsis; health related quality of life; functional status; chronic comorbid conditions; organ dysfunction