Hemodynamic and Perfusion Response to Drotrecogin Alfa (Activated) in Patients With Septic Shock - Full Text View

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)	Phase IV

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

Resource links provided by NLM:

MedlinePlus related topics: Sepsis

Drug Information available for: Drotrecogin alfa

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Cumulative Vasopressor Index (CVI) [ Time Frame: baseline to 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change From Baseline to 96 Hour Endpoint in Cumulative Vasopressor Index (CVI) [ Time Frame: Baseline, 96 hours ] [ Designated as safety issue: No ]
Mean Arterial Pressure [ Time Frame: baseline to 24 hours ] [ Designated as safety issue: No ]
Cardiovascular Performance Measures Obtained With a Pulmonary Artery Catheter - Cardiac Index [ Time Frame: Baseline to 24 Hours ] [ Designated as safety issue: No ]
Lactate Level [ Time Frame: Baseline to 6 Hours ] [ Designated as safety issue: No ]
Microcirculatory Measures From Sidestream Darkfield (SDF) Microscopy - Small Vessel Microvascular Flow Index (MFI) [ Time Frame: Baseline to 24 Hours ] [ Designated as safety issue: No ]
Sequential Organ Failure Assessment (SOFA) Score at Baseline and 24 Hours [ Time Frame: Baseline and 24 Hours ] [ Designated as safety issue: No ]
Changes in Creatinine Clearance (CrCl) [ Time Frame: Baseline to 24 hours ] [ Designated as safety issue: No ]
7 Day All-Cause in-Hospital Mortality [ Time Frame: baseline to 7 days ] [ Designated as safety issue: No ]
Endogenous Protein C Level [ Time Frame: Baseline to 24 Hours ] [ Designated as safety issue: No ]
Mixed Venous Oxygen Saturation [ Time Frame: Baseline to 24 Hours ] [ Designated as safety issue: No ]

Enrollment:	43
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 (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.

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
Results First Received:	October 31, 2008
Last Updated:	July 1, 2009
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
Anti-Infective Agents
Anticoagulants
Fibrinolytic Agents
Cardiovascular Agents
Inflammation

Sepsis
Fibrin Modulating Agents
Shock
Protein C
Shock, Septic
Vasoconstrictor Agents

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 August 30, 2009