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

Lilly

Status and phase: Completed; Phase 3

Conditions: Hypotension; Sepsis

Treatments: Drug: placebo; Drug: Drotrecogin Alfa (Activated)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00190788

6001

F1K-MC-EVBQ

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind