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Extended Therapy of Drotrecogin Alfa (Activated) 4 vs 7 Days Infusion

NCT ID: NCT00190788

Last Updated: 2007-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2007-05-31

Brief Summary

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The purpose of this study is to determine whether continued administration of Drotrecogin Alfa (Activated) up to additional 72 hours - after the so far recommended 96 hour infusion period - results in a more rapid resolution of hypotension in severe septic patients.

Detailed Description

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Conditions

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Sepsis Hypotension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Drotrecogin Alfa (Activated)

Intervention Type DRUG

placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Severe sepsis patients treated with 96 hour infusion of commercial Drotrecogin Alfa (Activated)
* Continue requirement of Vasopressor support after 96 hour commercial infusion

Exclusion Criteria

* Patients require extensive surgical procedures within next 3 days
* Patients with platelet count below 30,000/mm3
* Patients receiving therapeutic heparin of 15,000 units/day and more
* Patients not expected to survive 24 days
* Patients contraindicated as to the country specific registration
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

Principal Investigators

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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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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.

Loma Linda, California, United States

Site Status

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.

Paris, , France

Site Status

Countries

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Austria Belgium Germany Italy Poland Spain United Kingdom United States France

Other Identifiers

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F1K-MC-EVBQ

Identifier Type: -

Identifier Source: secondary_id

6001

Identifier Type: -

Identifier Source: org_study_id