Efficacy and Safety of Drotrecogin Alfa (Activated) in Adult Patients with Septic Shock
- Conditions
- Lack of circulating volume due to bacterial infection of the blood10018073
- Registration Number
- NL-OMON31460
- Lead Sponsor
- Eli Lilly
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
1. Patient must be an adult (18 years or older)
2. Patient must have evidence of an infection for which the patient is receiving intravenous antimicrobial therapy
3. Patient must have systemic inflammatory response syndrome (SIRS).
4. Patient must have septic shock
5. Patients must remain vasopressor dependent throughout the pretreatment period and through the time of randomization
Patients who, prior to the start of study drug, have received vasopressor therapy (at any dose) for greater than 24 hours or have sepsis-induced organ dysfunction for greater than 36 hours, patients who have had surgery performed within the 12-hour period immediately preceding the study drug infusion, have an active internal bleeding or are at increased risk for bleeding, patients who are not expected to survive 28 days given their preexisting uncorrectable medical condition or are receiving concommitant therapies that will have an impact on their wellbeing
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>All-cause mortalilty after 28 days</p><br>
- Secondary Outcome Measures
Name Time Method