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

Eli Lilly and Company1 site in 1 country43 target enrollmentNovember 2005

ConditionsSepsis Septic Shock

Drugsdrotrecogin alfa (activated)

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Sepsis
Sponsor: Eli Lilly and Company
Enrollment: 43
Locations: 1
Primary Endpoint: Cumulative Vasopressor Index (CVI)
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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).

Registry

clinicaltrials.gov

Start Date

November 2005

End Date

November 2007

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Eli Lilly and Company

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

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.

Secondary Outcomes

Lactate Level(Baseline to 6 Hours)
Cardiovascular Performance Measures Obtained With a Pulmonary Artery Catheter - Cardiac Index(Baseline to 24 Hours)
Change From Baseline to 96 Hour Endpoint in Cumulative Vasopressor Index (CVI)(Baseline, 96 hours)
Mean Arterial Pressure(baseline to 24 hours)
Microcirculatory Measures From Sidestream Darkfield (SDF) Microscopy - Small Vessel Microvascular Flow Index (MFI)(Baseline to 24 Hours)
Sequential Organ Failure Assessment (SOFA) Score at Baseline and 24 Hours(Baseline and 24 Hours)
Change From Baseline in Creatinine Clearance (CrCl) at 24 Hours(Baseline and 24 hours)
7 Day All-cause In-hospital Mortality(baseline to 7 days)
Endogenous Protein C Level(Baseline to 24 Hours)
Mixed Venous Oxygen Saturation(Baseline to 24 Hours)