Phase 4
N=43
Hemodynamic and Perfusion Response to Drotrecogin Alfa (Activated) in Patients With Septic Shock
Sepsis · Septic Shock
Bottom Line
View on ClinicalTrials.gov: NCT00279214 ↗Enrolled (actual)
43
Serious AEs
—
Results posted
Aug 2009
Primary outcome: Primary: Cumulative Vasopressor Index (CVI) — 2.3; 3.0; -2.0; -1.4 units on a scale — p=0.238
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- drotrecogin alfa (activated) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- —
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cumulative Vasopressor Index (CVI) |
2.3; 3.0; -2.0; -1.4 | 0.238 |
| SECONDARY Change From Baseline to 96 Hour Endpoint in Cumulative Vasopressor Index (CVI) |
0.4; 0.5; -3.7; -3.3 | 0.478 |
| SECONDARY Mean Arterial Pressure |
78.2; 75.6; 4.7; 2.5 | 0.442 |
| SECONDARY Cardiovascular Performance Measures Obtained With a Pulmonary Artery Catheter - Cardiac Index |
3.3; 3.2; -0.2; 0.1 | 0.704 |
| SECONDARY Lactate Level |
1.8; 2.8; -0.2; 0.4 | 0.061 |
| SECONDARY Microcirculatory Measures From Sidestream Darkfield (SDF) Microscopy - Small Vessel Microvascular Flow Index (MFI) |
2.70; 2.50; 2.95; 2.80; 2.56; 2.65 | 0.242 |
| SECONDARY Sequential Organ Failure Assessment (SOFA) Score at Baseline and 24 Hours |
8.5; 8.3; 7.8; 7.8 | 0.686 |
| SECONDARY Change From Baseline in Creatinine Clearance (CrCl) at 24 Hours |
-9.74; 1.66 | 0.165 |
| SECONDARY 7 Day All-cause In-hospital Mortality |
18; 13; 4; 8 | — |
| SECONDARY Endogenous Protein C Level |
38.7; 34.8; 48.2; 38.9; 54.7; 40.0 | 0.552 |
| SECONDARY Mixed Venous Oxygen Saturation |
69.6; 75.0; 3.7; 6.5 | 0.128 |
Summary
The study will evaluate the vasopressor requirement, hemodynamic response and measures of tissue perfusion in patients with septic shock receiving an infusion of drotrecogin alfa (activated) compared to patients not receiving drotrecogin alfa (activated).
Eligibility Criteria
Inclusion:
- 18 years of age or older with a diagnosis of septic shock
- presence of a pulmonary artery catheter (or central venous catheters)
- requiring vasopressor support despite adequate fluid resuscitation
- an intravenous steroid administered for septic shock, except for those patients who were tested and are responders to a corticotropin stimulation test, or patients who do not receive a steroid due to the clinical judgment of the treating physician, based on an alternate assessment (e.g. normal baseline cortisol).
Exclusion:
- Onset of first-sepsis induced organ dysfunction is greater than 24 hours from the time of informed consent
- Baseline measurements of pulmonary artery occlusive pressure (PAOP) 200 kg
- Are moribund (not expected to survive 24 hours)
- Are pregnant or are lactating and the milk is to be ingested by the infant (pregnancy status must be verified by urine or serum testing)
- Have not completed written informed consent signed by the patient or the patient's legal representative.
Data sourced from ClinicalTrials.gov (NCT00279214). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.