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

Eli Lilly and Company1,696 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,696

Conditions

Sepsis

Interventions

Drotrecogin alfa (activated)DRUG

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

PlaceboDRUG

0.9% sodium chloride, intravenous, 96 hours

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (150)

Outcomes

Primary Outcomes

28-Day All-Cause Mortality

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

Time frame: Day 28

Secondary Outcomes

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

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%).

Time frame: Day 28

Average Cardiovascular Sequential Organ Failure Assessment (SOFA) Score 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.

Time frame: Day 1 through Day 28

Average Respiratory Sequential Organ Failure Assessment (SOFA) Score 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.

Time frame: Day 1 through Day 28

Average Renal Sequential Organ Failure Assessment (SOFA) Score 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.

Time frame: Day 1 through Day 28

90-Day Mortality

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

Data from ClinicalTrials.gov

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