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Life After Pediatric Sepsis Evaluation

Life After Pediatric Sepsis Evaluation

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01415180
Acronym
LAPSE
Enrollment
389
Registered
2011-08-11
Start date
2013-06-01
Completion date
2018-06-01
Last updated
2022-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Septic Shock

Keywords

sepsis, health related quality of life, functional status, chronic comorbid conditions, organ dysfunction

Brief 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.

Interventions

None listed

Sponsors

The National Collaborative Pediatric Critical Care Research Network
CollaboratorNETWORK
Children's Hospital Los Angeles
CollaboratorOTHER
Children's Hospital of Michigan
CollaboratorOTHER
Children's Hospital of Philadelphia
CollaboratorOTHER
University of Pittsburgh
CollaboratorOTHER
University of California, Los Angeles
CollaboratorOTHER
C.S. Mott Children's Hospital
CollaboratorOTHER
Children's National Research Institute
CollaboratorOTHER
Phoenix Children's Hospital
CollaboratorOTHER
Texas A&M University
CollaboratorOTHER
Seattle Children's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Months to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Specific Aim 1: Measure alterations in HRQL/FS longitudinally among children with septic shock.Baseline, PICU discharge, 1, 3, 6, 12 months following PICU admission for sepsisHypotheses related to this specific aim include: 1.1 A majority of children with septic shock will demonstrate declination of generic HRQL/FS comparing baseline and one month post-enrollment measures. \[Incidence\] 1.2 Significant deterioration in generic HRQL/FS will occur among children with septic shock comparing baseline and one month post-enrollment measures. \[Magnitude\] 1.3 Normalization of HRQL/FS will be observed by 12 months for the majority of children surviving septic shock. \[Duration\]

Secondary

MeasureTime frameDescription
Specific Aim 2: Determine the association between the magnitude of septic shock related HRQL/FS deterioration with validated measures of sepsis-mediated organ dysfunction.Baseline, PICU discharge, 1, 3, 6, 12 months following PICU admission for sepsisHypotheses related to this specific aim include: 2.1 Magnitude of septic shock related generic HRQL/FS deterioration will be associated with area under the curve of validated organ dysfunction measures assessed daily during PICU stay for the sepsis event.
Specific Aim 3: Describe the association between longitudinal changes in HRQL/FS following septic shock with measures of parent, family, and home characteristics and pre-existing comorbidities.Baseline, PICU discharge, 1, 3, 6, 12 months following PICU admission for sepsisHypotheses related to this specific aim include: 3.1 Family and home characteristics (socio-economic status, parental educational attainment, family function, parental distress, and insurance status) will be associated with duration and magnitude of HRQL/FS alterations. 3.2 Complexity of chronic comorbid conditions will be associated with duration and magnitude of HRQL/FS alterations

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026