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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ 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 ]
  • 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 ]

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:
No publications provided

ClinicalTrials.gov Identifier: NCT00279214     History of Changes
Other Study ID Numbers: 9944, F1K-US-EVDA
Study First Received: December 15, 2005
Results First Received: October 31, 2008
Last Updated: August 26, 2009
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 22, 2014