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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 is a clinical trial that has completed, run by Seattle Children's Hospital. The registered enrollment target is 389 participants.

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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

Trial Details

FieldValue
Enrollment Target 389 participants
Start Date 2013-06-01
Est. Completion 2018-06-01

Sponsor

Seattle Children's Hospital

168 total trials

What the Registry Record Tells You About NCT01415180

The ClinicalTrials.gov registry entry for NCT01415180 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 389 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Seattle Children's Hospital, which has 168 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 0 interventions.

NCT01415180 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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