NCT01415180: LAPSE

Life After Pediatric Sepsis Evaluation

Completed Last updated 6 December 2022

What this trial tests

trial in Septic Shock in 389 participants. Completed in 1 June 2018.

Timeline

1 June 2013

Primary endpoint
1 June 2018

1 June 2018

Quick facts

Lead sponsor	Seattle Children's Hospital
Status	Completed
Study type	OBSERVATIONAL
Enrollment	389
Start date	1 June 2013
Primary completion	1 June 2018
Estimated completion	1 June 2018
Sites	11 locations across United States

Conditions studied

• Septic Shock — all drugs for Septic Shock →

Sponsor

Seattle Children's Hospital

Who can join

Adults 1 Month to 18, any sex, with Septic Shock. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Association of Pathogen Type With Outcomes of Children Encountering Community-Acquired Pediatric Septic Shock.
   Salud D, Reeder RW, Banks RK, Meert KL, et al · · 2022 · cited 11× · PMID 35687094 · DOI 10.1097/pcc.0000000000003001
2. Predicting functional and quality-of-life outcomes following pediatric sepsis: performance of PRISM-III and PELOD-2.
   Killien EY, Watson RS, Banks RK, Reeder RW, et al · · 2023 · cited 6× · PMID 37185949 · DOI 10.1038/s41390-023-02619-w
3. Oxygenation Severity Categories and Long-Term Quality of Life among Children who Survive Septic Shock.
   Kohne JG, Carlton EF, Gorga SM, Gebremariam A, et al · · 2024 · PMID 39629345 · DOI 10.1055/s-0042-1756307