Life After Pediatric Sepsis Evaluation

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.

Conditions

• Septic Shock

Sponsors & Collaborators

• The National Collaborative Pediatric Critical Care Research Network

  collaborator NETWORK

• Children's Hospital Los Angeles

  collaborator OTHER

• Children's Hospital of Michigan

  collaborator OTHER

• Children's Hospital of Philadelphia

  collaborator OTHER

• University of Pittsburgh

  collaborator OTHER

• University of California, Los Angeles

  collaborator OTHER

• C.S. Mott Children's Hospital

  collaborator OTHER

• Children's National Research Institute

  collaborator OTHER

• Phoenix Children's Hospital

  collaborator OTHER

• Texas A&M University

  collaborator OTHER

• Seattle Children's Hospital

  lead OTHER

Principal Investigators

• Jerry J. Zimmerman, MD, PhD · Seattle Children's Hospital

Eligibility

Min Age

1 Month

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-06-01

Primary Completion

2018-06-01

Completion

2018-06-01

Countries

• United States

Study Locations