Life After Pediatric Sepsis Evaluation (LAPSE)
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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 |
- 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]
- 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
| Estimated Enrollment: | 450 |
| 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.
|
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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 |
Children aged 0-18 admitted to a PICU for septic shock
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| Contact: Jerry J. Zimmerman, MD, PhD | 206-987-3862 | jerry.zimmerman@seattlechildrens.org |
| United States, Arizona | |
| Phoenix Children's Hospital | Not yet recruiting |
| Phoenix, Arizona, United States | |
| Contact: Murray Pollack, MD 602-546-0305 mpollack@phoenixchildrens.com | |
| United States, California | |
| Children's Hospital of Los Angeles | Not yet recruiting |
| Los Angeles, California, United States | |
| Contact: Christopher Newth, MD 323-361-2117 cnewth@chla.edu | |
| Principal Investigator: Christopher M Newth, MD | |
| Mattel Children's Hospital | Not yet recruiting |
| Los Angeles, California, United States | |
| Contact: Rick Harrison, MD 310-825-6752 rickharrison@mednet.ucla.edu | |
| Principal Investigator: Rick Harrison, MD | |
| United States, District of Columbia | |
| National Children's Hospital | Not yet recruiting |
| Washington, District of Columbia, United States | |
| Contact: David Wessel, MD 202-476-5047 dwessel@cnmc.org | |
| Principal Investigator: Davis Wessel, MD | |
| United States, Michigan | |
| Mott Children's Hospital | Not yet recruiting |
| Ann Arbor, Michigan, United States | |
| Contact: Thomas Shanley, MD 734-764-5302 tshanley@med.umich.edu | |
| Principal Investigator: Thomas Shanley, MD | |
| Children's Hospital of Michigan | Not yet recruiting |
| Detroit, Michigan, United States | |
| Contact: Kathleen Meert, MD 313-745-5891 kmeert@med.wayne.edu | |
| Principal Investigator: Kathleen Meert, MD | |
| United States, Pennsylvania | |
| Children's Hospital of Philadelphia | Not yet recruiting |
| Philadelphia, Pennsylvania, United States | |
| Contact: Robert Berg, MD 267-426-3014 bergra@email.chop.edu | |
| Principal Investigator: Robert Berg, MD | |
| Pittsburgh Children's Hospital | Not yet recruiting |
| Pittsburgh, Pennsylvania, United States | |
| Contact: Joseph Carcillo, MD 412-692-6737 carcilloja@ccm.upmc.edu | |
| Principal Investigator: Murray Pollack, MD | |
| Principal Investigator: Joseph Carcillo, MD | |
| United States, Texas | |
| Texas A&M University | |
| College Station, Texas, United States | |
| United States, Utah | |
| University of Utah | Not yet recruiting |
| Salt Lake City, Utah, United States | |
| Contact: J. Michael Dean, MD 801-581-5271 mike.dean@hsc.utah.edu | |
| Principal Investigator: J. Michael Dean, MD | |
| Sub-Investigator: Richard Holubkov, PhD | |
| United States, Washington | |
| Seattle Children's Hospital | Not yet recruiting |
| Seattle, Washington, United States, 98105 | |
| Contact: Jerry Zimmerman, MD, PhD 206-987-3862 jerry.zimmerman@seattlechildrens.org | |
| Principal Investigator: Jerry J. Zimmerman, MD, PhD | |
| Sub-Investigator: Rita Mangione-Smith, MD | |
| Sub-Investigator: Michelle Garrison, PhD | |
| Sub-Investigator: Tonya Palermo, PhD | |
| Sub-Investigator: John Neff, MD | |
| 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: | September 11, 2012 |
| 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:
|
Sepsis Shock Shock, Septic Infection |
Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes |
ClinicalTrials.gov processed this record on May 22, 2013