Hemodynamic and Perfusion Response to Drotrecogin Alfa (Activated) in Patients With Septic Shock

Phase 4

Completed

• Conditions: Sepsis; Septic Shock

• Registration Number: NCT00279214
• Lead Sponsor: Eli Lilly and Company

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2005-12-15
• Study First Submitted QC: 2006-01-17
• Study First Posted: 2006-01-19
• Study Completion: 2007-11
• Results First Submitted: 2008-10-31
• Results First Submitted QC: 2009-07-01
• Status Verified: 2009-08
• Results First Posted: 2009-08-17
• Last Update Submitted: 2009-08-26
• Last Update Posted: 2009-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cumulative Vasopressor Index (CVI)	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 Outcome Measures

Name	Time	Method
Change From Baseline to 96 Hour Endpoint in Cumulative Vasopressor Index (CVI)	Baseline, 96 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.
Mean Arterial Pressure	baseline to 24 hours
Cardiovascular Performance Measures Obtained With a Pulmonary Artery Catheter - Cardiac Index	Baseline to 24 Hours	Cardiac Index = cardiac output divided by body surface area.
Lactate Level	Baseline to 6 Hours	Measures of global tissue perfusion and oxygenation were assessed via lactate levels.
Microcirculatory Measures From Sidestream Darkfield (SDF) Microscopy - Small Vessel Microvascular Flow Index (MFI)	Baseline to 24 Hours	Per vessel category (and per quadrant), scored flow as follows: no flow=0, intermediate flow=1, sluggish flow=2, continuous flow=3. The MFI per vessel category calculated with formula (Q1+Q2+Q3+Q4)/4. Scores could range from 0 (sluggish flow) to 3 (continuous flow).
Sequential Organ Failure Assessment (SOFA) Score at Baseline and 24 Hours	Baseline and 24 Hours	The presence of 5 organ dysfunctions (cardiovascular, respiratory, renal, hepatic, coagulation) was assessed using a Sequential Organ Failure Assessment (SOFA) score. Each organ has a possible dysfunction score of 0 to 4, for a total SOFA score range of 0 (no organ dysfunction) to 20 (all organs with dysfunction).
Change From Baseline in Creatinine Clearance (CrCl) at 24 Hours	Baseline and 24 hours	CrCl = (urine creatinine\*urine volume)/(plasma creatinine\*time period of urine collection). Corrected CrCl = CrCl\*1.73/body surface area. Change in CrCl = Endpoint minus baseline.
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	Cardiovascular performance measures obtained with a pulmonary catheter as assessed by mixed venous oxygen saturation.

Trial Locations

Locations (1)

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.; 🇺🇸 Akron, Ohio, United States