TITLE

Extended drotrecogin alfa (activated) treatment in patients with prolonged septic shock

AUTHOR(S)
Dhainaut, Jean-Francois; Antonelli, Massimo; Wright, Patrick; Desachy, Arnaud; Reignier, Jean; Lavoue, Sylvain; Charpentier, Julien; Belger, Mark; Cobas-Meyer, Michael; Maier, Cornelia; Mignini, Mariano A.; Janes, Jonathan
PUB. DATE
July 2009
SOURCE
Intensive Care Medicine;Jul2009, Vol. 35 Issue 7, p1187
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
ABSTRACT
To determine the efficacy and safety of extended drotrecogin alfa (activated) (DAA) therapy. Multicentre, randomised, double-blind, placebo-controlled study. Sixty-four intensive care units in nine countries. Adults with severe sepsis and vasopressor-dependent hypotension after a 96-h infusion of standard DAA. A total of 193 patients received an intravenous infusion of extended DAA 24 µg/kg/h or sodium chloride placebo for a maximum of 72 h. At extended therapy initiation (baseline), DAA-group patients had lower protein C levels ( P = 0.23) and higher vasopressor requirements, particularly for the primary vasopressor used, norepinephrine ( P = 0.03), compared with placebo-group patients. DAA treatment did not result in a difference in the primary outcome of time to resolution of vasopressor-dependent hypotension versus placebo ( P = 0.419). However, few patients reached resolution (DAA 34%, placebo 40%) as most continued to require vasopressor support after 72 additional hours of treatment. Treatment did not reduce 28-day all-cause mortality and in-hospital mortality or improve organ function compared with placebo, although there was a lower percentage change in D-dimers ( P < 0.001) and increases in protein C levels were numerically greater on extended infusion. There was no difference in serious adverse events including bleeding events. Extended DAA treatment did not result in more rapid resolution of vasopressor-dependent hypotension, despite demonstrating anticipated biological effects on D-dimer and protein C levels. A reduced planned sample size combined with baseline imbalances in protein C levels and vasopressor requirements may have limited the ability to demonstrate a clinical benefit.
ACCESSION #
41885935

 

Related Articles

  • Tratamiento quirúrgico de las complicaciones del shock meningocóccico grave. Roca, P. Casteleiro; Miguez, J. Midón; Barreiro, J. García; Martelo Villar, F. // Cirugía Plástica Ibero-Latinoamericana;2010, Vol. 36 Issue 2, p155 

    Meningococcal shock is a relatively frequent disease with a serious prognosis, that causes a multiorganic failure with high mortality and Intensive Care Unit admission. Serious meningococcal shock causes tissue necrosis by uncertain physiopathology. In the last years, there is an increase of the...

  • Randomized, Placebo-Controlled Trial of HA-1A, a Human Monoclonal Antibody to Endotoxin, in Children with Meningococcal Septic Shock. Derkx, Bert; Wittes, Janet; McCloskey, Richard // Clinical Infectious Diseases;4/1/1999, Vol. 28 Issue 4, p770 

    Focuses on a study which examined the effectiveness of HA-1A, a human monoclonal antibody to endotoxin, in reducing mortality rate among children with a presumptive clinical diagnosis of meningococcal septic shock. Methodology; Treatment; Evaluation of the patients; Results.

  • Fluid management in the critically ill child. Raman, Sainath; Peters, Mark J. // Pediatric Nephrology;Jan2014, Vol. 29 Issue 1, p23 

    Fluid management has a major impact on the duration, severity and outcome of critical illness. The overall strategy for the acutely ill child should be biphasic. Aggressive volume expansion to support tissue oxygen delivery as part of early goal-directed resuscitation algorithms for...

  • Early goal-directed therapy versus 'early', 'goal-directed' therapy. Saleh, Ahmad // Intensive Care Medicine;Sep2015, Vol. 41 Issue 9, p1723 

    A letter to the editor is presented in response to the article "A Systematic Review and Meta-analysis of Early Goal-directed Therapy for Septic Shock: The ARISE, ProCESS and ProMISe Investigators" by D. C. Angus and colleagues in the 2015 issue.

  • Concomitant arginine-vasopressin and hydrocortisone therapy in severe septic shock: association with mortality. Torgersen, Christian; Luckner, Günter; Schröder, Daniel C. H.; Schmittinger, Christian A.; Rex, Christopher; Ulmer, Hanno; Dünser, Martin W. // Intensive Care Medicine;Sep2011, Vol. 37 Issue 9, p1432 

    Purpose: To evaluate the association between concomitant arginine-vasopressin (AVP)/hydrocortisone therapy and mortality in severe septic shock patients. Methods: This retrospective study included severe septic shock patients treated with supplementary AVP. To test the association between...

  • The Effect of Information Provision on Reduction of Errors in Intravenous Drug Preparation and Administration by Nurses in ICU and Surgical Wards. Abbasinazari, Mohammad; Zareh-Toranposhti, Samaneh; Hassani, Abdollah; Sistanizad, Mohammad; Azizian, Homa; Panahi, Yunes // Acta Medica Iranica;2012, Vol. 50 Issue 11, p771 

    Malpractice in preparation and administration of intravenous (IV) medications has been reported frequently. Inadequate knowledge of nurses has been reported as a cause of such errors. We aimed to evaluate the role of nurses' education via installation of wall posters and giving informative...

  • The Circle Continues Unbroken: Now Corticosteroids Are Not Effective for Septic Shock.  // Clinical Infectious Diseases;6/1/2008, Vol. 46 Issue 11, pvi 

    The article reports on the therapeutic effect of corticosteroid administration on patients with sepsis. Study shows that stress-dose steroid therapy should be given only in septic shock after blood pressure is determined to be poorly responsive to fluid and vasopressor therapy. It reveals that...

  • No additional benefit of intensive insulin therapy in patients treated with hydrocortisone for septic shock.  // Endocrine Today;Feb2010, Vol. 8 Issue 2, p34 

    The article discusses research on the benefits of intensive insulin therapy in patients who are under hydrocortisone treatment regimen for septic shock, published in the 2010 issue of the "Journal of the American Medical Association."

  • Selected treatment strategies for septic shock based on proposed mechanisms of pathogenesis. Natanson, Charles; Hoffman, William D.; Suffredini, Anthony F.; Eickhacker, Peter Q.; Danner, Robert L.; Natanson, C; Hoffman, W D; Suffredini, A F; Eichacker, P Q; Danner, R L // Annals of Internal Medicine;5/1/94, Vol. 120 Issue 9, p771 

    Purpose: To review selected new therapies for septic shock designed to inhibit bacterial toxins or endogenous mediators of inflammation.Data Sources: Scientific journals, scientific meeting proceedings, and Food and Drug Administration advisory committee...

Share

Read the Article

Courtesy of THE LIBRARY OF VIRGINIA

Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics