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This study has been withdrawn prior to enrollment.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

August 10, 2011
May 24, 2013
June 2013
June 2018   (final data collection date for primary outcome measure)
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]

1: Measure alterations in physical/psychosocial HRQL longitudinally in a cohort of children surviving septic shock. [ Time Frame: Baseline, PICU discharge, 1, 3, and 6 months following PICU admission for sepsis ] [ Designated as safety issue: No ]
1.1: Determine the incidence, and magnitude, of PedsQL™ Generic Core Scale ( PedsQL™ GCS) deterioration comparing assessments at baseline and one month following PICU admission. 1.2: Determine the duration of PedsQL™ GCS deterioration comparing longitudinal assessments at PICU discharge and one, three and six months following PICU admission. 1.3 Compare the incidence, intensity and duration of pediatric sepsis- associated HRQL changes among previously healthy children with children with chronic, complex conditions.
Complete list of historical versions of study NCT01415180 on ClinicalTrials.gov Archive Site
  • 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

  • 2: Quantify the relationship between HRQL deterioration (in the domains of activity, physical function and weakness) and actigraphy with extent of lean muscle protein catabolism during sepsis critical illness. [ Time Frame: Baseline, PICU discharge, 1, 3, 6 months following PICU admission for sepsis ] [ Designated as safety issue: No ]
    2.1: Determine the relationship between magnitude of HRQL deterioration with AUC of serial urinary 3MeHis/Cr ratios. 2.2: Determine the relationship between summation of subject actigraphy counts derived week 3-4 following PICU admission with AUC of serial urinary 3MeHis/Cr ratios. 2.3: Determine the relationship between AUC of serial urinary 3MeHis/Cr ratios with AUC of serial urinary cortisol/kg ratios.
  • 3: Describe possible associations between sepsis-associated HRQL deterioration with pre-existing co-morbidities and established sepsis clinical and biochemical MODS intensity measures. [ Time Frame: Baseline, PICU discharge, 1, 3, 6 months following PICU admission for sepsis ] [ Designated as safety issue: No ]
    3.1: Examine in a preliminary, exploratory fashion, potential relationships between HRQL deterioration, comparing baseline and 1 month post ICU assessments, with pre-existing co-morbidities and established measures of sepsis clinical and biochemical MODS intensity measures using regression analysis.
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Life After Pediatric Sepsis Evaluation
Life After Pediatric Sepsis Evaluation

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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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

Septic Shock
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  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
June 2018
June 2018   (final data collection date for primary outcome measure)

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
Both
1 Month to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01415180
SeattleChildrens
No
Jerry Zimmerman, Seattle Children's Hospital
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
Principal Investigator: Jerry J. Zimmerman, MD, PhD Seattle Children's Hospital
Seattle Children's Hospital
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP