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| ID | Type | Description | Link |
|---|---|---|---|
| F1K-MC-EVBQ |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drotrecogin Alfa (Activated) | Drug | |||
| placebo | Drug |
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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 | 92350 |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| C421124 | drotrecogin alfa activated |
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| Investigate safety profile of an extended infusion of DDA |
| 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 | 75679 | France |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |