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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00279214
First Posted: January 19, 2006
Last Update Posted: September 2, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Eli Lilly and Company
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Cumulative Vasopressor Index (CVI) [ Time Frame: baseline to 24 hours ]

Secondary Outcome Measures:
  • Change From Baseline to 96 Hour Endpoint in Cumulative Vasopressor Index (CVI) [ Time Frame: Baseline, 96 hours ]
  • Mean Arterial Pressure [ Time Frame: baseline to 24 hours ]
  • Cardiovascular Performance Measures Obtained With a Pulmonary Artery Catheter - Cardiac Index [ Time Frame: Baseline to 24 Hours ]
  • Lactate Level [ Time Frame: Baseline to 6 Hours ]
  • Microcirculatory Measures From Sidestream Darkfield (SDF) Microscopy - Small Vessel Microvascular Flow Index (MFI) [ Time Frame: Baseline to 24 Hours ]
  • Sequential Organ Failure Assessment (SOFA) Score at Baseline and 24 Hours [ Time Frame: Baseline and 24 Hours ]
  • Change From Baseline in Creatinine Clearance (CrCl) at 24 Hours [ Time Frame: Baseline and 24 hours ]
  • 7 Day All-cause In-hospital Mortality [ Time Frame: baseline to 7 days ]
  • Endogenous Protein C Level [ Time Frame: Baseline to 24 Hours ]
  • Mixed Venous Oxygen Saturation [ Time Frame: Baseline to 24 Hours ]

Enrollment: 43
Study Start Date: November 2005
Study Completion Date: November 2007
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
ClinicalTrials.gov Identifier: NCT00279214     History of Changes
Other Study ID Numbers: 9944
F1K-US-EVDA
First Submitted: December 15, 2005
First Posted: January 19, 2006
Results First Submitted: October 31, 2008
Results First Posted: August 17, 2009
Last Update Posted: September 2, 2009
Last Verified: August 2009

Additional relevant MeSH terms:
Shock
Shock, Septic
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Drotrecogin alfa activated
Protein C
Anti-Infective Agents
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action