Life After Pediatric Sepsis Evaluation (LAPSE)

This study has been withdrawn prior to enrollment.
(No funding)
Sponsor:
Collaborators:
The National Collaborative Pediatric Critical Care Research Network
Children's Hospital Los Angeles
Children's Hospital of Michigan
Children's Hospital of Philadelphia
Children's Hospital of Pittsburgh
Mattel Children's Hospital
Mott Children's Hospital
National Children's Hospital
Phoenix Children's Hospital
Texas A&M University
Information provided by (Responsible Party):
Jerry Zimmerman, Seattle Children's Hospital
ClinicalTrials.gov Identifier:
NCT01415180
First received: August 10, 2011
Last updated: May 24, 2013
Last verified: May 2013
  Purpose

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
Septic Shock

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Life After Pediatric Sepsis Evaluation

Resource links provided by NLM:


Further study details as provided by Seattle Children's Hospital:

Primary Outcome Measures:
  • Specific Aim 1: Measure alterations in HRQL/FS longitudinally among children with septic shock. [ Time Frame: Baseline, PICU discharge, 1, 3, 6, 12 months following PICU admission for sepsis ] [ Designated as safety issue: No ]

    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. [ Time Frame: Baseline, PICU discharge, 1, 3, 6, 12 months following PICU admission for sepsis ] [ Designated as safety issue: No ]

    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. [ Time Frame: Baseline, PICU discharge, 1, 3, 6, 12 months following PICU admission for sepsis ] [ Designated as safety issue: No ]

    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



Enrollment: 0
Study Start Date: June 2013
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   1 Month to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Children aged 0-18 admitted to a PICU for septic shock

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01415180

Locations
United States, Arizona
Phoenix Children's Hospital
Phoenix, Arizona, United States
United States, California
Mattel Children's Hospital
Los Angeles, California, United States
Children's Hospital of Los Angeles
Los Angeles, California, United States
United States, District of Columbia
National Children's Hospital
Washington, District of Columbia, United States
United States, Michigan
Mott Children's Hospital
Ann Arbor, Michigan, United States
Children's Hospital of Michigan
Detroit, Michigan, United States
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Pittsburgh Children's Hospital
Pittsburgh, Pennsylvania, United States
United States, Texas
Texas A&M University
College Station, Texas, United States
United States, Utah
University of Utah
Salt Lake City, Utah, United States
United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Seattle Children's Hospital
The National Collaborative Pediatric Critical Care Research Network
Children's Hospital Los Angeles
Children's Hospital of Michigan
Children's Hospital of Philadelphia
Children's Hospital of Pittsburgh
Mattel Children's Hospital
Mott Children's Hospital
National Children's Hospital
Phoenix Children's Hospital
Texas A&M University
Investigators
Principal Investigator: Jerry J. Zimmerman, MD, PhD Seattle Children's Hospital
  More Information

No publications provided

Responsible Party: Jerry Zimmerman, Principal Investigator, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT01415180     History of Changes
Other Study ID Numbers: SeattleChildrens
Study First Received: August 10, 2011
Last Updated: May 24, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Seattle Children's Hospital:
sepsis
health related quality of life
functional status
chronic comorbid conditions
organ dysfunction

Additional relevant MeSH terms:
Shock, Septic
Infection
Inflammation
Pathologic Processes
Sepsis
Shock
Systemic Inflammatory Response Syndrome

ClinicalTrials.gov processed this record on October 23, 2014