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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
43
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.
Camden, New Jersey, United States
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
Cumulative Vasopressor Index (CVI)
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.
Time frame: baseline to 24 hours
Change From Baseline to 96 Hour Endpoint in Cumulative Vasopressor Index (CVI)
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.
Time frame: Baseline, 96 hours
Mean Arterial Pressure
Time frame: baseline to 24 hours
Cardiovascular Performance Measures Obtained With a Pulmonary Artery Catheter - Cardiac Index
Cardiac Index = cardiac output divided by body surface area.
Time frame: Baseline to 24 Hours
Lactate Level
Measures of global tissue perfusion and oxygenation were assessed via lactate levels.
Time frame: Baseline to 6 Hours
Microcirculatory Measures From Sidestream Darkfield (SDF) Microscopy - Small Vessel Microvascular Flow Index (MFI)
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).
Time frame: Baseline to 24 Hours
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Sequential Organ Failure Assessment (SOFA) Score at 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).
Time frame: Baseline and 24 Hours
Change From Baseline in Creatinine Clearance (CrCl) at 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.
Time frame: Baseline and 24 hours
7 Day All-cause In-hospital Mortality
Time frame: baseline to 7 days
Endogenous Protein C Level
Time frame: Baseline to 24 Hours
Mixed Venous Oxygen Saturation
Cardiovascular performance measures obtained with a pulmonary catheter as assessed by mixed venous oxygen saturation.
Time frame: Baseline to 24 Hours