Hemodynamic and Perfusion Response to Drotrecogin Alfa (Activated) in Patients With Septic Shock

• Status: Completed
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Drotrecogin alfa activated; Protein C

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) < 12 mmHg or a central venous pressure (CVP) < 8 mmHg

• Patient requires continuous oxygen therapy by face-mask

• The presence of an advanced directive to withhold life-sustaining treatment, with the exception of a directive to withhold chest compressions only

• Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry

• Weight > 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.