Hypotension, Sepsis
Conditions
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.
Interventions
DRUGplacebo
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - 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
| Measure | Time frame |
|---|---|
| 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 | — |
| Investigate safety profile of an extended infusion of DDA | — |
Countries
France, United States
Outcome results
None listed