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Home > "I" Clinical Trials Conditions > Investigation of the Efficacy and Safety of Drotrecogin Alfa (Activated) in Pediatric Severe Sepsis.

Investigation of the Efficacy and Safety of Drotrecogin Alfa (Activated) in Pediatric Severe Sepsis.



Investigation of the Efficacy and Safety of Drotrecogin Alfa (Activated) in Pediatric Severe Sepsis.

For Condition: Sepsis
Status: Recruiting
Sponsor(s): Eli Lilly and Company ,
Synopsis: 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.
Details:
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: /17 Years
Genders: Both
Protocol Entry 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.
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Additional Information:
Study ID Numbers:
  6716; 
Study Start Date: 
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00049764

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