Clinical trial NCT00279214: Hemodynamic and Perfusion Response to Drotrecogin Alfa (Activated) in Patients With Septic Shock
Official title: An Evaluation of Vasopressor Requirement, Hemodynamic Response and Measures of Tissue Perfusion With the Administration of Drotrecogin Alfa (Activated) as Part of Physician-Directed Therapy in Patients With Septic Shock
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sepsis
Septic Shock
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2006-01-19
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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) \< 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.

Primary outcomes:
measure: Cumulative Vasopressor Index (CVI)
timeFrame: baseline to 24 hours
Secondary outcomes:
measure: Change From Baseline to 96 Hour Endpoint in Cumulative Vasopressor Index (CVI)
timeFrame: Baseline, 96 hours
measure: Mean Arterial Pressure
timeFrame: baseline to 24 hours
measure: Cardiovascular Performance Measures Obtained With a Pulmonary Artery Catheter - Cardiac Index
timeFrame: Baseline to 24 Hours
measure: Lactate Level
timeFrame: Baseline to 6 Hours
measure: Microcirculatory Measures From Sidestream Darkfield (SDF) Microscopy - Small Vessel Microvascular Flow Index (MFI)
timeFrame: Baseline to 24 Hours
measure: Sequential Organ Failure Assessment (SOFA) Score at Baseline and 24 Hours
timeFrame: Baseline and 24 Hours
measure: Change From Baseline in Creatinine Clearance (CrCl) at 24 Hours
timeFrame: Baseline and 24 hours
measure: 7 Day All-cause In-hospital Mortality
timeFrame: baseline to 7 days
measure: Endogenous Protein C Level
timeFrame: Baseline to 24 Hours
measure: Mixed Venous Oxygen Saturation
timeFrame: Baseline to 24 Hours
Other outcomes:
measure: Number of Participants With Bleeding Events
timeFrame: baseline to 7 days
Locations:
city: Camden
country: United States
facility: 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.
state: New Jersey
city: Akron
country: United States
facility: 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.
state: Ohio
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-651-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: