The purposes of this study are to determine:
1. Whether drotrecogin alfa (activated) helps children with severe sepsis survive their condition more often or recover faster than children who do not receive drotrecogin alfa (activated).
2. Whether drotrecogin alfa (activated) minimizes long term disabilities associated with severe sepsis.
3. The side effects that might be associated with drotrecogin alfa (activated) administration to children with severe sepsis.
Official Title
Conditions
-Sepsis
Study Type
Interventional
Study Design
Treatment
Further Details
The purposes of this study are to determine:1. Whether drotrecogin alfa (activated) helps children with severe sepsis survive their condition more often or recover faster than children who do not receive drotrecogin alfa (activated). 2. Whether drotrecogin alfa (activated) minimizes long term disabilities associated with severe sepsis.3. The side effects that might be associated with drotrecogin alfa (activated) administration to children with severe sepsis.
Study Start
Eligibility & Criteria
Ages Eligible for Study: up to 17 Years, Genders Eligible for Study: Both Criteria Inclusion Criteria:Suspected or proven acute infection. Abnormally high or low core body temperature Cardiovascular dysfunction which requires the use of vasoactive drugs (such as, dopamine, dobutamine, epinephrine) and is the result of severe sepsis. Respiratory dysfunction which requires the use of mechanical ventilation and is the result of severe sepsis. Exclusion Criteria:Patients at increased risk of bleeding. Patients at high risk for an intracranial bleed. Patients who have undergone a bone marrow transplant. Patients with end-stage renal disease. Patients whose family or primary care physician is unwilling to allow transfusion of blood products.
Total Enrolment
Contact Details
[1] Eli Lilly and Company[2] 1-877-CT Lilly (1-877-285-4559), Subiaco, Western Australia, Australia; RecruitingAll content and media on the HealthEngine Blog is created and published online for informational purposes only. It is not intended to be a substitute for professional medical advice and should not be relied on as health or personal advice. Always seek the guidance of your doctor or other qualified health professional with any questions you may have regarding your health or a medical condition. Never disregard the advice of a medical professional, or delay in seeking it because of something you have read on this Website. If you think you may have a medical emergency, call your doctor, go to the nearest hospital emergency department, or call the emergency services immediately.
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