Extended Therapy of Drotrecogin Alfa (Activated) 4 vs 7 Days Infusion
Phase 3
Completed
- Conditions
- SepsisHypotension
- Registration Number
- NCT00190788
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The purpose of this study is to determine whether continued administration of Drotrecogin Alfa (Activated) up to additional 72 hours - after the so far recommended 96 hour infusion period - results in a more rapid resolution of hypotension in severe septic patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
- Severe sepsis patients treated with 96 hour infusion of commercial Drotrecogin Alfa (Activated)
- Continue requirement of Vasopressor support after 96 hour commercial infusion
Exclusion Criteria
- Patients require extensive surgical procedures within next 3 days
- Patients with platelet count below 30,000/mm3
- Patients receiving therapeutic heparin of 15,000 units/day and more
- Patients not expected to survive 24 days
- Patients contraindicated as to the country specific registration
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method - To assess whether continued administration of Drotrecogin Alfa (Activated)for up to 72 additional hours after 96 hours infusion of commercial DDA results in more rapid resolution of vasopressor-dependent hypotension
- Secondary Outcome Measures
Name Time Method Investigate safety profile of an extended infusion of DDA Evaluate Reduction of 28-day all cause mortality Evaluate effects on various organ functions over 14 days Evaluate effects on the concentration of various biomarkers
Trial Locations
- Locations (1)
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
🇫🇷Paris, France