Literature DB >> 17111246

Evaluation of drotrecogin alpha use in a Belgian university hospital.

Isabel Spriet1, Wouter Meersseman, Alexander Wilmer, Geert Meyfroidt, Minne Casteels, Ludo Willems.   

Abstract

OBJECTIVE: Sepsis remains a major cause of mortality in ICU patients, despite advances in therapy. Drotrecogin alpha (Drot AA), a recombinant human activated protein C with anti-inflammatory and anticoagulant properties, has proven to be successful in patients with at least one organ failure. Our goal was to evaluate the data in patients with sepsis and at least two organ dysfunctions in a large university hospital in Belgium.
SETTING: The study was conducted at the medical and surgical intensive care units of the 1850-bed university hospital of Leuven, Belgium.
METHODS: We retrospectively evaluated the use of Drot AA during a 2.5 year period. At baseline patients' demographics, type of infection, APACHE II (acute physiology and chronic health evaluation), SOFA (sequential organ failure assessment), DIC (diffuse intravascular coagulation) score and number of organ failures were obtained. Overall hospital mortality was defined as primary outcome measure. Special attention was paid to bleeding, the main side effect of Drot AA. MAIN OUTCOME MEASURE: Evalution of hospital and ICU mortality in patients treated with Drot AA for severe sepsis.
RESULTS: Drot AA was administered to 23 patients with sepsis and at least 2 organ dysfunctions; all patients started treatment within 24 h of onset of the second organ failure. Mean age was 59 years. Mean number of organ failures was 3. Overall hospital mortality rate was 47.8%. A 28-day mortality of 26% was found, comparable with the 28-day mortality rate of the PROWESS trial. Bleeding, requiring more than 3 units of blood, occurred in 1 patient. Although underlying co-morbidity was more pronounced in survivors, non-survivors had a slightly higher median APACHE II, higher SOFA score and higher DIC score. However, the number of organ failures was identical in both groups.
CONCLUSIONS: Overall hospital mortality rate was similar as observed in the Belgian Registry and 28-day mortality was equal to the results of the PROWESS study. Due to the limited number of patients, it is not clear if patients should be selected based on APACHE II, DIC or number of organ failures. However, selection based on number of organ failures is more appropriate due to intrinsic problems of the APACHE II score.

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Year:  2006        PMID: 17111246     DOI: 10.1007/s11096-006-9045-3

Source DB:  PubMed          Journal:  Pharm World Sci        ISSN: 0928-1231


  16 in total

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2.  Risks and benefits of activated protein C treatment for severe sepsis.

Authors:  H Shaw Warren; Anthony F Suffredini; Peter Q Eichacker; Robert S Munford
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3.  Epidemiology of severe sepsis in the United States: analysis of incidence, outcome, and associated costs of care.

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Journal:  Crit Care Med       Date:  2001-07       Impact factor: 7.598

4.  Reassessing recombinant human activated protein C for sepsis: time for a new randomized controlled trial.

Authors:  Peter Q Eichacker; Robert L Danner; Anthony F Suffredini; Xizhong Cui; Charles Natanson
Journal:  Crit Care Med       Date:  2005-10       Impact factor: 7.598

5.  Severe sepsis and therapy with activated protein C.

Authors:  Joseph E Parrillo
Journal:  N Engl J Med       Date:  2005-09-29       Impact factor: 91.245

6.  Efficacy and safety of recombinant human activated protein C for severe sepsis.

Authors:  G R Bernard; J L Vincent; P F Laterre; S P LaRosa; J F Dhainaut; A Lopez-Rodriguez; J S Steingrub; G E Garber; J D Helterbrand; E W Ely; C J Fisher
Journal:  N Engl J Med       Date:  2001-03-08       Impact factor: 91.245

7.  Low levels of protein C are associated with poor outcome in severe sepsis.

Authors:  S B Yan; J D Helterbrand; D L Hartman; T J Wright; G R Bernard
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8.  Treatment effects of drotrecogin alfa (activated) in patients with severe sepsis with or without overt disseminated intravascular coagulation.

Authors:  J-F Dhainaut; S B Yan; D E Joyce; V Pettilä; B Basson; J T Brandt; D P Sundin; M Levi
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Review 9.  Surviving Sepsis Campaign guidelines for management of severe sepsis and septic shock.

Authors:  R Phillip Dellinger; Jean M Carlet; Henry Masur; Herwig Gerlach; Thierry Calandra; Jonathan Cohen; Juan Gea-Banacloche; Didier Keh; John C Marshall; Margaret M Parker; Graham Ramsay; Janice L Zimmerman; Jean-Louis Vincent; Mitchell M Levy
Journal:  Crit Care Med       Date:  2004-03       Impact factor: 7.598

10.  Use of an integrated clinical trial database to evaluate the effect of timing of drotrecogin alfa (activated) treatment in severe sepsis.

Authors:  Jean-Louis Vincent; James O'Brien; Arthur Wheeler; Xavier Wittebole; Rekha Garg; Benjamin L Trzaskoma; David P Sundin
Journal:  Crit Care       Date:  2006-05-09       Impact factor: 9.097

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  4 in total

1.  The international PROGRESS registry of patients with severe sepsis: drotrecogin alfa (activated) use and patient outcomes.

Authors:  Greg Martin; Frank M Brunkhorst; Jonathan M Janes; Konrad Reinhart; David P Sundin; Kassandra Garnett; Richard Beale
Journal:  Crit Care       Date:  2009-06-30       Impact factor: 9.097

2.  Growing insights into the potential benefits and risks of activated protein C administration in sepsis: a review of preclinical and clinical studies.

Authors:  Laith Altaweel; Daniel Sweeney; Xizhong Cui; Amisha Barochia; Charles Natanson; Peter Q Eichacker
Journal:  Biologics       Date:  2009-09-15

3.  Filter survival time and requirement of blood products in patients with severe sepsis receiving drotrecogin alfa (activated) and requiring renal replacement therapy.

Authors:  Luigi Camporota; Eleonora Corno; Eleonora Menaldo; John Smith; Katie Lei; Richard Beale; Duncan Wyncoll
Journal:  Crit Care       Date:  2008-12-18       Impact factor: 9.097

Review 4.  Practical aspects of treatment with drotrecogin alfa (activated).

Authors:  Luigi Camporota; Duncan Wyncoll
Journal:  Crit Care       Date:  2007       Impact factor: 9.097

  4 in total

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