Extended Therapy of Drotrecogin Alfa (Activated) 4 vs 7 Days Infusion
Completed · Phase 3 · Has a placebo group
Conditions studied: Sepsis, Hypotension
In brief
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.
Key facts
- Study ID
- NCT00190788
- Run by
- Eli Lilly and Company
- People needed
- 200
- Starts
- 2004-06-01
- Expected to finish
- 2007-05-01
- Last updated by the study team
- 2007-10-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Severe sepsis patients treated with 96 hour infusion of commercial Drotrecogin Alfa (Activated)
- Continue requirement of Vasopressor support after 96 hour commercial infusion
You may not qualify if…
- 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
Where it is running
- 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. — Loma Linda, California, United States
- 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
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.