Life After Pediatric Sepsis Evaluation

NCT01415180 | Completed

• 1 other identifier: SeattleChildrens
• Study Type: observational
• Target: 389
• Locations: 1 country
• Sites: 11

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. The long-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.

Conditions

Septic Shock

Keywords

sepsis; health related quality of life; functional status; chronic comorbid conditions; organ dysfunction

Outcome Measures

Primary Outcomes (1)

• Specific Aim 1: Measure alterations in HRQL/FS longitudinally among children with septic shock.

  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

Secondary Outcomes (2)

• 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

• 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

Study Arms (2)

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 Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seattle Children's Hospital: lead
• The National Collaborative Pediatric Critical Care Research Network: collaborator
• Children's Hospital Los Angeles: collaborator
• Children's Hospital of Michigan: collaborator
• Children's Hospital of Philadelphia: collaborator
• University of Pittsburgh: collaborator
• University of California, Los Angeles: collaborator
• C.S. Mott Children's Hospital: collaborator
• Children's National Research Institute: collaborator
• Phoenix Children's Hospital: collaborator
• Texas A&M University: collaborator

Study Sites (11)

Phoenix Children's Hospital

Phoenix, Arizona, United States

Location

Children's Hospital of Los Angeles

Los Angeles, California, United States

Location

Mattel Children's Hospital

Los Angeles, California, United States

Location

National Children's Hospital

Washington D.C., District of Columbia, United States

Location

Mott Children's Hospital

Ann Arbor, Michigan, United States

Location

Children's Hospital of Michigan

Detroit, Michigan, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Location

Pittsburgh Children's Hospital

Pittsburgh, Pennsylvania, United States

Location

Texas A&M University

College Station, Texas, United States

Location

University of Utah

Salt Lake City, Utah, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Related Publications (5)

• 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.

  PMID: 32058369 RESULT

• 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.

  PMID: 32058370 RESULT

• 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.

  PMID: 32667767 RESULT

• 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.

  PMID: 32541376 RESULT

• 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.

  PMID: 32569242 RESULT

MeSH Terms

Conditions

Shock, Septic; Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Jerry J. Zimmerman, MD, PhD

  Seattle Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 10, 2011
• First Posted: August 11, 2011
• Study Start: June 1, 2013
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: December 6, 2022

Record last verified: 2022-12

Locations

US (11)