Life After Pediatric Sepsis Evaluation

NCT ID: NCT01415180

Last Updated: 2022-12-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 389 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-06-01
• Study Completion Date: 2018-06-01

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.

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.

Conditions

Septic Shock

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Children: chronic, complex conditions

Children with chronic, complex conditions prior to the sepsis episode, expected to comprise about 40-50% of the study population.

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The National Collaborative Pediatric Critical Care Research Network

NETWORK

Sponsor Role: collaborator

Children's Hospital Los Angeles

OTHER

Sponsor Role: collaborator

Children's Hospital of Michigan

OTHER

Sponsor Role: collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: collaborator

C.S. Mott Children's Hospital

OTHER

Sponsor Role: collaborator

Children's National Research Institute

OTHER

Sponsor Role: collaborator

Phoenix Children's Hospital

OTHER

Sponsor Role: collaborator

Texas A&M University

OTHER

Sponsor Role: collaborator

Seattle Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jerry Zimmerman

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jerry J. Zimmerman, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seattle Children's Hospital

Locations

Phoenix Children's Hospital

Phoenix, Arizona, United States

Children's Hospital of Los Angeles

Los Angeles, California, United States

Mattel Children's Hospital

Los Angeles, California, United States

National Children's Hospital

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

Mott Children's Hospital

Ann Arbor, Michigan, United States

Children's Hospital of Michigan

Detroit, Michigan, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Pittsburgh Children's Hospital

Pittsburgh, Pennsylvania, United States

Texas A&M University

College Station, Texas, United States

University of Utah

Salt Lake City, Utah, United States

Seattle Children's Hospital

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 32058369 (View on PubMed)

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.

Reference Type: RESULT

PMID: 32058370 (View on PubMed)

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.

Reference Type: RESULT

PMID: 32667767 (View on PubMed)

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.

Reference Type: RESULT

PMID: 32541376 (View on PubMed)

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.

Reference Type: RESULT

PMID: 32569242 (View on PubMed)

Other Identifiers

SeattleChildrens

Identifier Type: -

Identifier Source: org_study_id