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Evaluate Protein C Levels in Severe Sepsis Patients on Drotrecogin Alfa (Activated)

NCT ID: NCT00386425

Last Updated: 2010-12-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

486 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2009-08-31

Brief Summary

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In this trial, patients with severe sepsis and low protein C levels will receive drotrecogin alfa (activated) at the normal, approved dose and time of administration \[24 microgram/kilogram/hour (mcg/kg/hour) for 96 hours\] or will receive the normal, approved dose or higher doses than the approved dose for a longer administration time. After the drug administration is complete, the protein C levels from the patients receiving the normal, approved dose will be compared to protein C levels from patients receiving the normal, approved dose or higher dose for a longer duration to determine if the protein C levels improve faster if given higher dose and/or longer administration time.

Note: The protocol was amended to remove the option of shorter infusion durations.

Detailed Description

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Conditions

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Severe Sepsis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Standard therapy

24 microgram/kilogram/hour (mcg/kg/hr) for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours

Group Type EXPERIMENTAL

Drotrecogin alfa (activated)

Intervention Type DRUG

intravenous

Alternative therapy:moderate protein C deficiency

24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 48 to 144 hours (original protocol) or an additional 72 to 144 hours (amended protocol)

Group Type EXPERIMENTAL

Drotrecogin alfa (activated)

Intervention Type DRUG

intravenous

Alternative therapy:severe protein C deficiency

24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for 48 to 144 hours (original protocol) or an additional 72 to 144 hours (amended protocol)

Group Type EXPERIMENTAL

Drotrecogin alfa (activated)

Intervention Type DRUG

intravenous

Interventions

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Drotrecogin alfa (activated)

intravenous

Intervention Type DRUG

Other Intervention Names

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Xigris LY203638

Eligibility Criteria

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Inclusion Criteria

* Must be 18 years or older
* Must have a suspected or proven infection
* Must have two or more sepsis-associated organ dysfunctions

Exclusion Criteria

* Documented multiple organ dysfunction greater than 24 hours prior to start of study drug
* Actual body weight less than 30 kg or more than 135 kg
* Platelet count less than 30,000/mm\^3
* Active internal bleeding or at increased risk of bleeding
* Not expected to survive 28 days given the patient's pre-existing uncorrectable medical condition
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Eli Lilly

Principal Investigators

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Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Phoenix, Arizona, United States

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Scottsdale, Arizona, United States

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Fresno, California, United States

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Loma Linda, California, United States

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Stanford, California, United States

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Washington D.C., District of Columbia, United States

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Orlando, Florida, United States

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Idaho Falls, Idaho, United States

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Indianapolis, Indiana, United States

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Louisville, Kentucky, United States

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Portland, Maine, United States

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Minneapolis, Minnesota, United States

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St Louis, Missouri, United States

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Greensboro, North Carolina, United States

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Abington, Pennsylvania, United States

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Rapid City, South Dakota, United States

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Houston, Texas, United States

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Brussels, , Belgium

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Ghent, , Belgium

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Vancouver, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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Halifax, Nova Scotia, Canada

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London, Ontario, Canada

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Fleurimont, Quebec, Canada

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Helsinki, , Finland

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Kuopio, , Finland

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Oulu, , Finland

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Tampere, , Finland

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Angoulême, , France

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La Roche-sur-Yon, , France

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Limoges, , France

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Poitiers, , France

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Tours, , France

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Hamburg, , Germany

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Jena, , Germany

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Leipzig, , Germany

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San Juan, , Puerto Rico

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Sabadell, , Spain

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Reading, Berkshire, United Kingdom

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Brighton, East Sussex, United Kingdom

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Cottingham, East Yorkshire, United Kingdom

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London, Greater London, United Kingdom

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Waterloo, London, United Kingdom

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Kings Lynn, Norfolk, United Kingdom

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Birmingham, West Midlands, United Kingdom

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Countries

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Argentina Australia Italy Sweden United States Belgium Canada Finland France Germany Puerto Rico Spain United Kingdom

References

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Shorr AF, Janes JM, Artigas A, Tenhunen J, Wyncoll DL, Mercier E, Francois B, Vincent JL, Vangerow B, Heiselman D, Leishman AG, Zhu YE, Reinhart K; RESPOND investigators. Randomized trial evaluating serial protein C levels in severe sepsis patients treated with variable doses of drotrecogin alfa (activated). Crit Care. 2010;14(6):R229. doi: 10.1186/cc9382. Epub 2010 Dec 21.

Reference Type DERIVED
PMID: 21176144 (View on PubMed)

Other Identifiers

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F1K-MC-EVDK

Identifier Type: OTHER

Identifier Source: secondary_id

10553

Identifier Type: -

Identifier Source: org_study_id