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NCT01415180 · ClinicalTrials.gov registry record
Life After Pediatric Sepsis Evaluation
A clinical trial, sponsored by Seattle Children's Hospital.
- Completed
- Registry status
- 389
- Enrollment target
NCT01415180: Completed study, sponsored by Seattle Children's Hospital.
NCT01415180 is a clinical trial that has completed, run by Seattle Children's Hospital. The registered enrollment target is 389 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01415180 has completed, sponsored by Seattle Children's Hospital.
- COMPLETED
- Registry status
- 389 participants
- Enrollment target
Study 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 obje
Primary Outcome
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. \[Du
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 389 participants |
| Start Date | 2013-06-01 |
| Est. Completion | 2018-06-01 |
What the finished NCT01415180 record still lists
NCT01415180 is an observational study that tracks outcomes without assigning an intervention. The registered 389 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01415180 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01415180 about?
NCT01415180 is a clinical study titled "Life After Pediatric Sepsis Evaluation". 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 cri...
What is the current status of trial NCT01415180?
This trial is currently completed. The enrollment target is 389 participants. The study started on 2013-06-01. Estimated completion is 2018-06-01.
Who is sponsoring clinical trial NCT01415180?
This trial is sponsored by Seattle Children's Hospital, which has 168 total clinical trials registered on ClinicalTrials.gov.
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