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

Lilly

Status and phase

Completed

Phase 4

Conditions

Septic Shock

Sepsis

Treatments

Drug: drotrecogin alfa (activated)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00279214

F1K-US-EVDA

9944

Details and patient eligibility

About

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).

Enrollment

43 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.