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

Sepsis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00279214
• Other study ID #: 9944
• Secondary ID: F1K-US-EVDA
• Status: Completed
• Phase: Phase 4
• First received: December 15, 2005
• Last updated: August 26, 2009
• Start date: November 2005
• Est. completion date: November 2007

Study information

• Verified date: August 2009
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sepsis
• Septic Shock
• Shock
• Shock, Septic

Intervention

Drug:
• drotrecogin alfa (activated)

Locations

Country	Name	City	State
United States	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	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative Vasopressor Index (CVI)		baseline to 24 hours	No
Secondary	Change From Baseline to 96 Hour Endpoint in Cumulative Vasopressor Index (CVI)		Baseline, 96 hours	No
Secondary	Mean Arterial Pressure		baseline to 24 hours	No
Secondary	Cardiovascular Performance Measures Obtained With a Pulmonary Artery Catheter - Cardiac Index		Baseline to 24 Hours	No
Secondary	Lactate Level		Baseline to 6 Hours	No
Secondary	Microcirculatory Measures From Sidestream Darkfield (SDF) Microscopy - Small Vessel Microvascular Flow Index (MFI)		Baseline to 24 Hours	No
Secondary	Sequential Organ Failure Assessment (SOFA) Score at Baseline and 24 Hours		Baseline and 24 Hours	No
Secondary	Change From Baseline in Creatinine Clearance (CrCl) at 24 Hours		Baseline and 24 hours	No
Secondary	7 Day All-cause In-hospital Mortality		baseline to 7 days	No
Secondary	Endogenous Protein C Level		Baseline to 24 Hours	No
Secondary	Mixed Venous Oxygen Saturation		Baseline to 24 Hours	No

External Links

•   Lilly Clinical Trial Registry