LAPSE: Life After Pediatric Sepsis Evaluation

Sponsor

Seattle Children's Hospital (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01415180

Collaborator

The National Collaborative Pediatric Critical Care Research Network (Other), Children's Hospital Los Angeles (Other), Children's Hospital of Michigan (Other), Children's Hospital of Philadelphia (Other), University of Pittsburgh (Other), Mattel Children's Hospital (Other), C.S. Mott Children's Hospital (Other), National Children's Hospital (Other), Phoenix Children's Hospital (Other), Texas A&M University (Other)

Enrollment

Locations

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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. 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.

Condition or Disease	Intervention/Treatment	Phase
Septic Shock

Study Design

Study Type:

Observational

Actual Enrollment :

0 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Life After Pediatric Sepsis Evaluation

Study Start Date :

Jun 1, 2013

Anticipated Primary Completion Date :

Jun 1, 2018

Anticipated Study Completion Date :

Jun 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Children: previously healthy Previously healthy children, without chronic disease prior to the sepsis episode, expected to comprise about 50-60% of the total study population.
Children: chronic, complex conditions Children with chronic, complex conditions prior to the sepsis episode, expected to comprise about 40-50% of the study population.

Outcome Measures

Primary Outcome Measures

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 sepsis]
Hypotheses 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 Outcome Measures

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 sepsis]
Hypotheses 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 sepsis]
Hypotheses 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Month to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Phoenix Children's Hospital	Phoenix	Arizona	United States
2	Children's Hospital of Los Angeles	Los Angeles	California	United States
3	Mattel Children's Hospital	Los Angeles	California	United States
4	National Children's Hospital	Washington	District of Columbia	United States
5	Mott Children's Hospital	Ann Arbor	Michigan	United States
6	Children's Hospital of Michigan	Detroit	Michigan	United States
7	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	United States
8	Pittsburgh Children's Hospital	Pittsburgh	Pennsylvania	United States
9	Texas A&M University	College Station	Texas	United States
10	University of Utah	Salt Lake City	Utah	United States
11	Seattle Children's Hospital	Seattle	Washington	United States	98105