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Completed

NCT Number: NCT00604214

Efficacy and Safety of Drotrecogin Alfa (Activated) in Adult Patients With Septic Shock

The purpose of this placebo-controlled study is to determine if drotrecogin alfa (activated) treatment provides significant mortality reduction improvement in patients with septic shock compared with placebo treatment in patients receiving the current standard of care for septic shock. This study will also assess the effectiveness of drotrecogin alfa (activated) in reducing 28-day mortality in patients with septic shock and concomitant severe protein C deficiency.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary 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., Garran, Australian Capital Territory, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must be 18 years or older
  • Must have evidence of infection
  • Must have systemic inflammatory response syndrome (SIRS)
  • Must have vasopressor-dependent septic shock

Exclusion criteria

  • Have received vasopressor therapy (at any dose) for greater than 24 hours prior to the start of study drug
  • Have sepsis-induced organ dysfunction for greater than 36 hours prior to the start of the study drug infusion
  • Have single organ dysfunction and recent surgery (within 30 days of study entry)
  • Have had surgery performed within the 12-hour period immediately preceding the study drug infusion, or are postoperative with evidence of active bleeding, or have planned or anticipated surgery during the infusion period
  • Are not expected to survive 28 days given their preexisting uncorrectable medical condition

Treatment and study plan

Drotrecogin Alfa (Activated)

Drug

24 microgram/kilogram/hour, intravenous, 96 hours (hr)

Other names: LY203638, Xigris

Placebo

Drug

0.9% sodium chloride, intravenous, 96 hours

Primary outcomes

  1. 28-Day All-Cause Mortality

    Time frame: Day 28

    Expressed as percentage of participants who died from any cause at Day 28 endpoint.

Secondary outcomes

  1. 28-Day All-Cause Mortality in Participants With Severe Protein C Deficiency

    Time frame: Day 28

    Expressed as percentage of participants who died from any cause at Day 28 endpoint. Participants with severe protein C deficiency are those who had a protein C level ≤ half the lower limit of normal (LLN) (≤40%).

  2. Average Cardiovascular Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28

    Time frame: Day 1 through Day 28

    Scores range from 0 (normal) to 4 (organ failure) with an increasing score indicating increasing cardiovascular dysfunction. A non-surviving participant receives a score of 4 (worst score) for the day of death and every day thereafter.

  3. Average Respiratory Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28

    Time frame: Day 1 through Day 28

    Scores range from 0 (normal) to 4 (organ failure) with an increasing score indicating increasing respiratory dysfunction. A non-surviving participant receives a score of 4 (worst score) for the day of death and every day thereafter.

  4. Average Renal Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28

    Time frame: Day 1 through Day 28

    Scores range from 0 (normal) to 4 (organ failure) with an increasing score indicating increasing renal dysfunction. A non-surviving participant receives a score of 4 (worst score) for the day of death and every day thereafter.

  5. 90-Day Mortality

    Time frame: Day 90

    Expressed as percentage of participants who died from any cause at Day 90 endpoint.

  6. 180-Day Mortality

    Time frame: Day 180

    Expressed as percentage of participants who died from any cause at Day 180 endpoint.

  7. Median Survival Time

    Time frame: Day 180

  8. EuroQoL Questionnaire-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) Scores at Baseline, Days 28, 90 and 180

    Time frame: Baseline and Days 28 and 90 and 180

    EQ-5D VAS assesses caregiver's impression of participant's overall health state. Scores range from 0 (worst health state) to 100 (best health state), with higher scores indicating a better health state.

  9. EuroQoL Questionnaire-5 Dimensions (EQ-5D) Total Scores at Baseline, Days 28, 90 and 180

    Time frame: Baseline and Days 28 and 90 and 180

    The EQ-5D is used to assess participant's overall health. Consists of 5 items: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each item has 3 severity levels (no, some, severe problems). Calculated from EQ-5D, total scores (United States [US] Index Score) range from 0 (worst quality of life) to 1.00 (best quality of life).

  10. Quality of Life Short Form-12 (SF-12) Scores at Baseline, Days 28, 90 and 180

    Time frame: Baseline and Days 28 and 90 and 180

    SF-12 was used as an instrument to measure participants' physical wellbeing (physical component) and mental wellbeing (mental component). Scores for each component range from 0-100, with 0= lowest wellbeing, and 100=highest wellbeing.

  11. Percentage of Participants Discontinued Due to Adverse Events Any Time From Baseline Through Day 28 Endpoint

    Time frame: Baseline through Day 28

Other outcomes

  1. Percentage of Participants With Serious Bleeding Events Within System Organ Class Any Time From Baseline Through Day 28

    Time frame: Baseline through Day 28

    Percentage of participants who experienced serious bleeding events are reported by System Organ Class (SOC) term based on MedDRA 14.0. For a bleeding to qualify as a serious event, it would have to meet the standard definition of a serious adverse event or be a central nervous system bleeding or a bleeding event that lead to administration of ≥3 units packed red blood cells/day for 2 consecutive days.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study of Drotrecogin Alfa (Activated) Administered as a Continuous 96-hr Infusion to Adult Patients With Septic Shock

Important dates

Study start
2008
Primary completion
2011
Study completion
2012
First posted
Jan 30, 2008
Registry last updated
Sep 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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