Evaluate Protein C Levels in Severe Sepsis Patients on Drotrecogin Alfa (Activated)
Summary
In this trial, patients with severe sepsis and low protein C levels will receive drotrecogin alfa (activated) at the normal, approved dose and time of administration \[24 microgram/kilogram/hour (mcg/kg/hour) for 96 hours\] or will receive the normal, approved dose or higher doses than the approved dose for a longer administration time. After the drug administration is complete, the protein C levels from the patients receiving the normal, approved dose will be compared to protein C levels from patients receiving the normal, approved dose or higher dose for a longer duration to determine if the protein C levels improve faster if given higher dose and/or longer administration time. Note: The protocol was amended to remove the option of shorter infusion durations.
Timeline
- Start
- 2006-11
- Primary completion
- 2009-08
- Completion
- 2009-08
Outcome
Met primary endpoint
paper The study met its primary objective of increased protein C levels in patients receiving alternative therapy PMID 21176144 ↗
paper The difference in absolute change in protein C from Day 1 to Day 7 between the two therapy groups was 7% (P = 0.011). PMID 21176144 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Drotrecogin alfa (activated) | Protein / enzyme biologic | 24 ug/kg | Intravenous |
| Subject | Drotrecogin alfa (activated) | Protein / enzyme biologic | 30 ug/kg | Intravenous |
| Subject | Drotrecogin alfa (activated) | Protein / enzyme biologic | 36 ug/kg | Intravenous |