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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00279214
First received: December 15, 2005
Last updated: August 26, 2009
Last verified: August 2009

December 15, 2005
August 26, 2009
November 2005
Not Provided
Cumulative Vasopressor Index (CVI) [ Time Frame: baseline to 24 hours ] [ Designated as safety issue: No ]
Reduction of vasopressor requirement during the first 24 hours of therapy
Complete list of historical versions of study NCT00279214 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Change From Baseline in Creatinine Clearance (CrCl) at 24 Hours [ Time Frame: Baseline and 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 ]
  • - 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.
Not Provided
Not Provided
 
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).

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Sepsis
  • Septic Shock
Drug: drotrecogin alfa (activated)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
November 2007
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00279214
9944, F1K-US-EVDA
Not Provided
Not Provided
Eli Lilly and Company
Not Provided
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