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

This study has been completed.

First Received: December 15, 2005 Last Updated: December 21, 2007 History of Changes

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00279214

Purpose

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).

Condition	Intervention	Phase
Sepsis Septic Shock	Drug: drotrecogin alfa (activated) Drug: placebo	Phase IV

MedlinePlus related topics: Sepsis

Drug Information available for: Drotrecogin alfa

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Reduction of vasopressor requirement during the first 24 hours of therapy

Secondary Outcome Measures:

Mean Arterial Pressure
Cardiovascular performance measures obtained with a pulmonary artery catheter
Measures of global tissue perfusion and oxygenation
Microcirculatory measures from sidestream darkfield (SDF) microscopy
Change in Sequential Organ Failure Assessment (SOFA) score
Changes in creatinine clearance
7 day all-cause in-hospital mortality
Protein C Activity.

Estimated Enrollment:	40
Study Start Date:	November 2005
Study Completion Date:	November 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion:

18 years of age or older with a diagnosis of septic shock
presence of a pulmonary artery catheter
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

Exclusion:

Onset of first-sepsis induced organ dysfunction is greater than 22 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00279214

Locations

United States, New Jersey
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.
Camden, New Jersey, United States, 08103
United States, Ohio
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.
Akron, Ohio, United States, 44307

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director:

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)

Eli Lilly and Company

More Information

Additional Information:

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	9944, F1K-US-EVDA
Study First Received:	December 15, 2005
Last Updated:	December 21, 2007
ClinicalTrials.gov Identifier:	NCT00279214 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Systemic Inflammatory Response Syndrome
Drotrecogin alfa activated
Fibrin Modulating Agents
Sepsis
Anticoagulants
Protein C

Shock
Shock, Septic
Vasoconstrictor Agents
Fibrinolytic Agents
Cardiovascular Agents
Inflammation

Additional relevant MeSH terms:

Systemic Inflammatory Response Syndrome
Drotrecogin alfa activated
Anti-Infective Agents
Anticoagulants
Molecular Mechanisms of Pharmacological Action
Hematologic Agents
Fibrinolytic Agents
Cardiovascular Agents
Infection

Pharmacologic Actions
Inflammation
Fibrin Modulating Agents
Sepsis
Pathologic Processes
Shock
Protein C
Therapeutic Uses
Shock, Septic

ClinicalTrials.gov processed this record on May 07, 2009