Drotrecogin Alfa (Activated) Improves Respiratory and Cardiovascular Function in Patients with Severe Sepsis

2.50
Hdl Handle:
http://hdl.handle.net/10755/162842
Type:
Presentation
Title:
Drotrecogin Alfa (Activated) Improves Respiratory and Cardiovascular Function in Patients with Severe Sepsis
Abstract:
Drotrecogin Alfa (Activated) Improves Respiratory and Cardiovascular Function in Patients with Severe Sepsis
Conference Sponsor:Emergency Nurses Association
Conference Year:2004
Author:Turlo, Mary Ann, RN, MSN
P.I. Institution Name:Lilly Research Laboratories, Eli Lilly and Company
Title:Clinical Development Associate
Contact Address:Lilly Corporate Center, Indianapolis, IN, 46285, USA
Contact Telephone:(317) 433-6818
Co-Authors:Kathleen Solotkin, MSN, RN, CEN
Purpose: The timely assessment and treatment of patients with severe sepsis is a critical determinant in
the efficacy of therapy, in which emergency nurses play an important role. Cardiovascular and respiratory
dysfunction are common components of severe sepsis that are known to strongly influence patient outcomes.
Although the administration of drotrecogin alfa (activated) [DrotAA] has been shown to reduce
mortality in adult severe sepsis patients at high risk of death, its effects on individual organ system function
remain incompletely defined. Here we describe the capacity of DrotAA to improve or preserve cardiovascular
and respiratory function.
Design: Prospectively collected data from two randomized, double-blind, placebo-controlled trials of
DrotAA.
Setting and Sample: Results from a single site Phase 1B study of healthy human subjects (n = 16) and a
multi-center Phase 3 trial (PROWESS) of severe sepsis patients (n = 1690) are presented.
Methodology: In the single site study, healthy human subjects from an experimentally-induced endotoxemia
model were given DrotAA (24 micrograms/kg/hr) versus placebo; mean arterial pressure (MAP) was measured
every 30 minutes during the 8-hour drug infusion period. Between-group comparisons were performed
with repeated measures ANOVA. In PROWESS, severe sepsis patients received DrotAA (24 micrograms/kg/hr) or
placebo for 96 hours. Included here are secondary comparative analyses of time-to-resolution of cardiovascular
organ dysfunction (Cox regression) and the number of vasopressor-free and ventilator-free days
(Wilcoxon rank-sum).
Results: In the endotoxemia study, subjects in the DrotAA group maintained a higher overall MAP during
the infusion period (p = 0.02). In PROWESS, the average time from first documented organ dysfunction to
start of infusion was 17.4 plus or minus 11.1 hours. Time-to-resolution of cardiovascular organ dysfunction was significantly
shorter over days 1 to 7 in patients treated with DrotAA compared with placebo (p = 0.009).
Additionally, patients receiving DrotAA had significantly increased vasopressor-free (p = 0.016) and ventilator-
free (p = 0.047) days compared to placebo.
Conclusions: DrotAA prevented endotoxin-induced hypotension, and expedited resolution of cardiovascular
and respiratory organ dysfunction in severe sepsis patients. In addition to increasing overall survival
in severe sepsis, administration of DrotAA may promote more efficient usage of hospital resources. By providing
accurate and rapid identification, assessment, and treatment of severe sepsis patients, emergency
nurses may be able to significantly affect survival and outcomes. [Poster Presentation]
Repository Posting Date:
27-Oct-2011
Date of Publication:
17-Oct-2011
Sponsors:
Emergency Nurses Association

Full metadata record

DC FieldValue Language
dc.typePresentationen_GB
dc.titleDrotrecogin Alfa (Activated) Improves Respiratory and Cardiovascular Function in Patients with Severe Sepsisen_GB
dc.identifier.urihttp://hdl.handle.net/10755/162842-
dc.description.abstract<table><tr><td colspan="2" class="item-title">Drotrecogin Alfa (Activated) Improves Respiratory and Cardiovascular Function in Patients with Severe Sepsis</td></tr><tr class="item-sponsor"><td class="label">Conference Sponsor:</td><td class="value">Emergency Nurses Association</td></tr><tr class="item-year"><td class="label">Conference Year:</td><td class="value">2004</td></tr><tr class="item-author"><td class="label">Author:</td><td class="value">Turlo, Mary Ann, RN, MSN</td></tr><tr class="item-institute"><td class="label">P.I. Institution Name:</td><td class="value">Lilly Research Laboratories, Eli Lilly and Company</td></tr><tr class="item-author-title"><td class="label">Title:</td><td class="value">Clinical Development Associate</td></tr><tr class="item-address"><td class="label">Contact Address:</td><td class="value">Lilly Corporate Center, Indianapolis, IN, 46285, USA</td></tr><tr class="item-phone"><td class="label">Contact Telephone:</td><td class="value">(317) 433-6818</td></tr><tr class="item-email"><td class="label">Email:</td><td class="value">maryannturlo@lilly.com</td></tr><tr class="item-co-authors"><td class="label">Co-Authors:</td><td class="value">Kathleen Solotkin, MSN, RN, CEN</td></tr><tr><td colspan="2" class="item-abstract">Purpose: The timely assessment and treatment of patients with severe sepsis is a critical determinant in<br/>the efficacy of therapy, in which emergency nurses play an important role. Cardiovascular and respiratory<br/>dysfunction are common components of severe sepsis that are known to strongly influence patient outcomes.<br/>Although the administration of drotrecogin alfa (activated) [DrotAA] has been shown to reduce<br/>mortality in adult severe sepsis patients at high risk of death, its effects on individual organ system function<br/>remain incompletely defined. Here we describe the capacity of DrotAA to improve or preserve cardiovascular<br/>and respiratory function.<br/>Design: Prospectively collected data from two randomized, double-blind, placebo-controlled trials of<br/>DrotAA.<br/>Setting and Sample: Results from a single site Phase 1B study of healthy human subjects (n = 16) and a<br/>multi-center Phase 3 trial (PROWESS) of severe sepsis patients (n = 1690) are presented.<br/>Methodology: In the single site study, healthy human subjects from an experimentally-induced endotoxemia<br/>model were given DrotAA (24 micrograms/kg/hr) versus placebo; mean arterial pressure (MAP) was measured<br/>every 30 minutes during the 8-hour drug infusion period. Between-group comparisons were performed<br/>with repeated measures ANOVA. In PROWESS, severe sepsis patients received DrotAA (24 micrograms/kg/hr) or<br/>placebo for 96 hours. Included here are secondary comparative analyses of time-to-resolution of cardiovascular<br/>organ dysfunction (Cox regression) and the number of vasopressor-free and ventilator-free days<br/>(Wilcoxon rank-sum).<br/>Results: In the endotoxemia study, subjects in the DrotAA group maintained a higher overall MAP during<br/>the infusion period (p = 0.02). In PROWESS, the average time from first documented organ dysfunction to<br/>start of infusion was 17.4 plus or minus 11.1 hours. Time-to-resolution of cardiovascular organ dysfunction was significantly<br/>shorter over days 1 to 7 in patients treated with DrotAA compared with placebo (p = 0.009).<br/>Additionally, patients receiving DrotAA had significantly increased vasopressor-free (p = 0.016) and ventilator-<br/>free (p = 0.047) days compared to placebo.<br/>Conclusions: DrotAA prevented endotoxin-induced hypotension, and expedited resolution of cardiovascular<br/>and respiratory organ dysfunction in severe sepsis patients. In addition to increasing overall survival<br/>in severe sepsis, administration of DrotAA may promote more efficient usage of hospital resources. By providing<br/>accurate and rapid identification, assessment, and treatment of severe sepsis patients, emergency<br/>nurses may be able to significantly affect survival and outcomes. [Poster Presentation]</td></tr></table>en_GB
dc.date.available2011-10-27T10:35:05Z-
dc.date.issued2011-10-17en_GB
dc.date.accessioned2011-10-27T10:35:05Z-
dc.description.sponsorshipEmergency Nurses Associationen_GB
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