Extended Therapy of Drotrecogin Alfa (Activated) 4 vs 7 Days Infusion

• Status: Completed
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Drotrecogin alfa activated; Protein C

Criteria

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