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

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. Identifier: NCT00279214
Recruitment Status : Completed
First Posted : January 19, 2006
Results First Posted : August 17, 2009
Last Update Posted : September 2, 2009
Information provided by:
Eli Lilly and Company

December 15, 2005
January 19, 2006
October 31, 2008
August 17, 2009
September 2, 2009
November 2005
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Cumulative Vasopressor Index (CVI) [ Time Frame: baseline to 24 hours ]
Reduction of vasopressor requirement during the first 24 hours of therapy
Complete list of historical versions of study NCT00279214 on Archive Site
  • 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 ]
  • - 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.
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Hemodynamic and Perfusion Response to Drotrecogin Alfa (Activated) in Patients With Septic Shock
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
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).
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Phase 4
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Sepsis
  • Septic Shock
Drug: drotrecogin alfa (activated)
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
November 2007
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  • 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).


  • 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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Eli Lilly and Company
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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
Eli Lilly and Company
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP