Assessment of Severe Sepsis in Children: Experiences from Pediatric Patients Receiving Drotrecogin Alfa (Activated)

2.50
Hdl Handle:
http://hdl.handle.net/10755/163065
Type:
Presentation
Title:
Assessment of Severe Sepsis in Children: Experiences from Pediatric Patients Receiving Drotrecogin Alfa (Activated)
Abstract:
Assessment of Severe Sepsis in Children: Experiences from Pediatric Patients Receiving Drotrecogin Alfa (Activated)
Conference Sponsor:Emergency Nurses Association
Conference Year:2004
Author:Short, Mary A., RN MSN
P.I. Institution Name:Lilly Research Laboratories, Eli Lilly and Company
Title:Sr. Therapeutic Associate
Contact Address:Lilly Corporate Center, Indianapolis, IN, 46285, USA
Contact Telephone:(317) 276-9565
Co-Authors:Mary Ann Turlo, RN, MSN
Purpose: Approximately 5% of severe sepsis-related cases occur in children; approximately 7% of mortality
in children is sepsis related. Although approved for the reduction of mortality in adult severe sepsis
patients at high risk of death, the safety, and efficacy of drotrecogin alfa (activated) [DrotAA] is not yet
established in children. Severe sepsis in children can be difficult to identify, but timely assessment and
treatment by emergency nurses can significantly improve outcomes.
Design: Retrospective analysis of six open-label (i.e., subjects and investigators were aware of treatment)
studies in patients with severe sepsis receiving DrotAA.
Setting: Data are included from over 400 sites in 25 countries.
Sample: Data were evaluated for 334 patients (newborn to 18 years) with severe sepsis or purpura fulminans.
All patients met the clinical diagnosis of severe sepsis (infection, > 1 sepsis-induced organ dysfunction,
and evidence of systemic inflammation). Written, informed consent was obtained from patients or
authorized representatives.
Methodology: Baseline characteristics are described for children receiving DrotAA (doses ranging from 6
to 36 micrograms/kg/hr, most receiving 24 micrograms/kg/hr). Pharmacokinetic and coagulopathy data are described for a
subset of 83 children.
Results: Systemic inflammatory signs included tachycardia, tachypnea, hyper- or hypothermia, and abnormal
white cell count. Approximately fifty percent of children presented with all four signs. Systemic
(blood) infection was the most common site of primary infection (42.9%), followed by CNS (14.3%), and
intra-abdominal (14.3%). The most common microorganism was Neisseria meningitidis (27.9%).
Abnormalities were observed in the following organ systems or laboratory tests (% patients with abnormal
values shown): Cardiovascular (90%), respiratory (85%), D-dimer levels (100%), protein C (75%), and prothrombin
time (83.3%). Weight-adjusted clearance of DrotAA was not significantly affected by age or
weight, and elimination was rapid following discontinuation of infusion. DrotAA administration was associated
with increased protein C levels and platelet counts and decreased D-dimer and prothrombin times in
all age groups. Four bleeding events considered life threatening were observed during infusion (1.2%) of
which none were fatal.
Conclusion: Emergency nurses are critical in the assessment and treatment of severe sepsis. Shock, respiratory
dysfunction, and increased coagulopathy (thrombin generation/suppressed fibrinolysis) are common
signs of severe sepsis in children; timely assessment of these signs may improve patient outcomes.
Pharmacokinetic/pharmacodynamic responses of children to DrotAA were similar to adults. DrotAA administration
was associated with improved coagulopathy measures; however, a placebo-controlled trial (ongoing)
is needed to investigate the benefit/risk profile of DrotAA in pediatric patients with severe sepsis. [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.titleAssessment of Severe Sepsis in Children: Experiences from Pediatric Patients Receiving Drotrecogin Alfa (Activated)en_GB
dc.identifier.urihttp://hdl.handle.net/10755/163065-
dc.description.abstract<table><tr><td colspan="2" class="item-title">Assessment of Severe Sepsis in Children: Experiences from Pediatric Patients Receiving Drotrecogin Alfa (Activated)</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">Short, Mary A., 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">Sr. Therapeutic 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) 276-9565</td></tr><tr class="item-co-authors"><td class="label">Co-Authors:</td><td class="value">Mary Ann Turlo, RN, MSN</td></tr><tr><td colspan="2" class="item-abstract">Purpose: Approximately 5% of severe sepsis-related cases occur in children; approximately 7% of mortality<br/>in children is sepsis related. Although approved for the reduction of mortality in adult severe sepsis<br/>patients at high risk of death, the safety, and efficacy of drotrecogin alfa (activated) [DrotAA] is not yet<br/>established in children. Severe sepsis in children can be difficult to identify, but timely assessment and<br/>treatment by emergency nurses can significantly improve outcomes.<br/>Design: Retrospective analysis of six open-label (i.e., subjects and investigators were aware of treatment)<br/>studies in patients with severe sepsis receiving DrotAA.<br/>Setting: Data are included from over 400 sites in 25 countries.<br/>Sample: Data were evaluated for 334 patients (newborn to 18 years) with severe sepsis or purpura fulminans.<br/>All patients met the clinical diagnosis of severe sepsis (infection, &gt; 1 sepsis-induced organ dysfunction,<br/>and evidence of systemic inflammation). Written, informed consent was obtained from patients or<br/>authorized representatives.<br/>Methodology: Baseline characteristics are described for children receiving DrotAA (doses ranging from 6<br/>to 36 micrograms/kg/hr, most receiving 24 micrograms/kg/hr). Pharmacokinetic and coagulopathy data are described for a<br/>subset of 83 children.<br/>Results: Systemic inflammatory signs included tachycardia, tachypnea, hyper- or hypothermia, and abnormal<br/>white cell count. Approximately fifty percent of children presented with all four signs. Systemic<br/>(blood) infection was the most common site of primary infection (42.9%), followed by CNS (14.3%), and<br/>intra-abdominal (14.3%). The most common microorganism was Neisseria meningitidis (27.9%).<br/>Abnormalities were observed in the following organ systems or laboratory tests (% patients with abnormal<br/>values shown): Cardiovascular (90%), respiratory (85%), D-dimer levels (100%), protein C (75%), and prothrombin<br/>time (83.3%). Weight-adjusted clearance of DrotAA was not significantly affected by age or<br/>weight, and elimination was rapid following discontinuation of infusion. DrotAA administration was associated<br/>with increased protein C levels and platelet counts and decreased D-dimer and prothrombin times in<br/>all age groups. Four bleeding events considered life threatening were observed during infusion (1.2%) of<br/>which none were fatal.<br/>Conclusion: Emergency nurses are critical in the assessment and treatment of severe sepsis. Shock, respiratory<br/>dysfunction, and increased coagulopathy (thrombin generation/suppressed fibrinolysis) are common<br/>signs of severe sepsis in children; timely assessment of these signs may improve patient outcomes.<br/>Pharmacokinetic/pharmacodynamic responses of children to DrotAA were similar to adults. DrotAA administration<br/>was associated with improved coagulopathy measures; however, a placebo-controlled trial (ongoing)<br/>is needed to investigate the benefit/risk profile of DrotAA in pediatric patients with severe sepsis. [Poster Presentation]</td></tr></table>en_GB
dc.date.available2011-10-27T10:38:57Z-
dc.date.issued2011-10-17en_GB
dc.date.accessioned2011-10-27T10:38:57Z-
dc.description.sponsorshipEmergency Nurses Associationen_GB
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