- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01415180
Life After Pediatric Sepsis Evaluation (LAPSE)
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Arizona
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Phoenix, Arizona, United States
- Phoenix Children's Hospital
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California
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Los Angeles, California, United States
- Children's Hospital of Los Angeles
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Los Angeles, California, United States
- Mattel Children's Hospital
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District of Columbia
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Washington, District of Columbia, United States
- National Children's Hospital
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Michigan
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Ann Arbor, Michigan, United States
- Mott Children's Hospital
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Detroit, Michigan, United States
- Children's Hospital of Michigan
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Pennsylvania
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Philadelphia, Pennsylvania, United States
- Children's Hospital of Philadelphia
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Pittsburgh, Pennsylvania, United States
- Pittsburgh Children's Hospital
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Texas
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College Station, Texas, United States
- Texas A&M University
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Utah
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Salt Lake City, Utah, United States
- University of Utah
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Washington
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Seattle, Washington, United States, 98105
- Seattle Children's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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
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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] |
Baseline, PICU discharge, 1, 3, 6, 12 months following PICU admission for sepsis
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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
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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. |
Baseline, PICU discharge, 1, 3, 6, 12 months following PICU admission for sepsis
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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
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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 |
Baseline, PICU discharge, 1, 3, 6, 12 months following PICU admission for sepsis
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jerry J. Zimmerman, MD, PhD, Seattle Children's Hospital
Publications and helpful links
General Publications
- Zimmerman JJ, Banks R, Berg RA, Zuppa A, Newth CJ, Wessel D, Pollack MM, Meert KL, Hall MW, Quasney M, Sapru A, Carcillo JA, McQuillen PS, Mourani PM, Wong H, Chima RS, Holubkov R, Coleman W, Sorenson S, Varni JW, McGalliard J, Haaland W, Whitlock K, Dean JM, Reeder RW; Life After Pediatric Sepsis Evaluation (LAPSE) Investigators. Critical Illness Factors Associated With Long-Term Mortality and Health-Related Quality of Life Morbidity Following Community-Acquired Pediatric Septic Shock. Crit Care Med. 2020 Mar;48(3):319-328. doi: 10.1097/CCM.0000000000004122.
- Zimmerman JJ, Banks R, Berg RA, Zuppa A, Newth CJ, Wessel D, Pollack MM, Meert KL, Hall MW, Quasney M, Sapru A, Carcillo JA, McQuillen PS, Mourani PM, Wong H, Chima RS, Holubkov R, Coleman W, Sorenson S, Varni JW, McGalliard J, Haaland W, Whitlock K, Dean JM, Reeder RW; Life After Pediatric Sepsis Evaluation (LAPSE) Investigators. Trajectory of Mortality and Health-Related Quality of Life Morbidity Following Community-Acquired Pediatric Septic Shock. Crit Care Med. 2020 Mar;48(3):329-337. doi: 10.1097/CCM.0000000000004123.
- Meert KL, Reeder R, Maddux AB, Banks R, Berg RA, Zuppa A, Newth CJ, Wessel D, Pollack MM, Hall MW, Quasney M, Sapru A, Carcillo JA, McQuillen PS, Mourani PM, Chima RS, Holubkov R, Sorenson S, Varni JW, McGalliard J, Haaland W, Whitlock KB, Dean JM, Zimmerman JJ; and the Life After Pediatric Sepsis Evaluation (LAPSE) Investigators. Trajectories and Risk Factors for Altered Physical and Psychosocial Health-Related Quality of Life After Pediatric Community-Acquired Septic Shock. Pediatr Crit Care Med. 2020 Oct;21(10):869-878. doi: 10.1097/PCC.0000000000002374.
- Murphy LK, Palermo TM, Meert KL, Reeder R, Dean JM, Banks R, Berg RA, Carcillo JA, Chima R, McGalliard J, Haaland W, Holubkov R, Mourani PM, Pollack MM, Sapru A, Sorenson S, Varni JW, Zimmerman J. Longitudinal Trajectories of Caregiver Distress and Family Functioning After Community-Acquired Pediatric Septic Shock. Pediatr Crit Care Med. 2020 Sep;21(9):787-796. doi: 10.1097/PCC.0000000000002404.
- Starr MC, Banks R, Reeder RW, Fitzgerald JC, Pollack MM, Meert KL, McQuillen PS, Mourani PM, Chima RS, Sorenson S, Varni JW, Hingorani S, Zimmerman JJ; Life After Pediatric Sepsis Evaluation (LAPSE) Investigators. Severe Acute Kidney Injury Is Associated With Increased Risk of Death and New Morbidity After Pediatric Septic Shock. Pediatr Crit Care Med. 2020 Sep;21(9):e686-e695. doi: 10.1097/PCC.0000000000002418.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SeattleChildrens
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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