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

August 26, 2009 updated by: Eli Lilly and Company

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New Jersey
      • Camden, New Jersey, United States, 08103
        • 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.
    • Ohio
      • Akron, Ohio, United States, 44307
        • 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.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative Vasopressor Index (CVI)
Time Frame: baseline to 24 hours
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline to 96 Hour Endpoint in Cumulative Vasopressor Index (CVI)
Time Frame: Baseline, 96 hours
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, 96 hours
Mean Arterial Pressure
Time Frame: baseline to 24 hours
baseline to 24 hours
Cardiovascular Performance Measures Obtained With a Pulmonary Artery Catheter - Cardiac Index
Time Frame: Baseline to 24 Hours
Cardiac Index = cardiac output divided by body surface area.
Baseline to 24 Hours
Lactate Level
Time Frame: Baseline to 6 Hours
Measures of global tissue perfusion and oxygenation were assessed via lactate levels.
Baseline to 6 Hours
Microcirculatory Measures From Sidestream Darkfield (SDF) Microscopy - Small Vessel Microvascular Flow Index (MFI)
Time Frame: Baseline to 24 Hours
Per vessel category (and per quadrant), scored flow as follows: no flow=0, intermediate flow=1, sluggish flow=2, continuous flow=3. The MFI per vessel category calculated with formula (Q1+Q2+Q3+Q4)/4. Scores could range from 0 (sluggish flow) to 3 (continuous flow).
Baseline to 24 Hours
Sequential Organ Failure Assessment (SOFA) Score at Baseline and 24 Hours
Time Frame: Baseline and 24 Hours
The presence of 5 organ dysfunctions (cardiovascular, respiratory, renal, hepatic, coagulation) was assessed using a Sequential Organ Failure Assessment (SOFA) score. Each organ has a possible dysfunction score of 0 to 4, for a total SOFA score range of 0 (no organ dysfunction) to 20 (all organs with dysfunction).
Baseline and 24 Hours
Change From Baseline in Creatinine Clearance (CrCl) at 24 Hours
Time Frame: Baseline and 24 hours
CrCl = (urine creatinine*urine volume)/(plasma creatinine*time period of urine collection). Corrected CrCl = CrCl*1.73/body surface area. Change in CrCl = Endpoint minus baseline.
Baseline and 24 hours
7 Day All-cause In-hospital Mortality
Time Frame: baseline to 7 days
baseline to 7 days
Endogenous Protein C Level
Time Frame: Baseline to 24 Hours
Baseline to 24 Hours
Mixed Venous Oxygen Saturation
Time Frame: Baseline to 24 Hours
Cardiovascular performance measures obtained with a pulmonary catheter as assessed by mixed venous oxygen saturation.
Baseline to 24 Hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Bleeding Events
Time Frame: baseline to 7 days
Serious bleeding event resulted in one of following outcomes, or was significant for any reason: initial/ prolonged inpatient hospitalization; life-threatening experience; persistent or significant disability/incapacity; congenital anomaly/birth defect. Intracranial hemorrhage was also considered serious bleeding event.
baseline to 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

December 15, 2005

First Submitted That Met QC Criteria

January 17, 2006

First Posted (Estimate)

January 19, 2006

Study Record Updates

Last Update Posted (Estimate)

September 2, 2009

Last Update Submitted That Met QC Criteria

August 26, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Other Study ID Numbers

  • 9944 (Other Identifier: CTEP)
  • F1K-US-EVDA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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