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

NCT00279214 | Completed Phase 4 Results

• 2 other identifiers: 9944F1K-US-EVDA
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Sepsis; Septic Shock

Outcome Measures

Primary Outcomes (1)

• Cumulative Vasopressor Index (CVI)

  CVI is sum of rankings for all vasopressors being used by patient at given time. Based on relative potency and dosing range for each vasopressor, each vasopressor was assigned ranking of 1 (low dosage) to 4 (high dosage). Range of CVI is between 1 and 20.

  baseline to 24 hours

Secondary Outcomes (10)

• Change From Baseline to 96 Hour Endpoint in Cumulative Vasopressor Index (CVI)

  Baseline, 96 hours

• Mean Arterial Pressure

  baseline to 24 hours

• Cardiovascular Performance Measures Obtained With a Pulmonary Artery Catheter - Cardiac Index

  Baseline to 24 Hours

• Lactate Level

  Baseline to 6 Hours

• Microcirculatory Measures From Sidestream Darkfield (SDF) Microscopy - Small Vessel Microvascular Flow Index (MFI)

  Baseline to 24 Hours

Other Outcomes (1)

• Number of Participants With Bleeding Events

  baseline to 7 days

Interventions

drotrecogin alfa (activated) DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (2)

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, 08103, United States

Location

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, 44307, United States

Location

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Sepsis; Shock, Septic

Interventions

drotrecogin alfa activated

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

1-800-545-5979

Study Officials

• 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 15, 2005
• First Posted: January 19, 2006
• Study Start: November 1, 2005
• Study Completion: November 1, 2007
• Last Updated: September 2, 2009
• Results First Posted: August 17, 2009

Record last verified: 2009-08

Locations

US (2)