Recombinant human activated protein c for adults with septic shock: A randomized controlled trial

American Journal of Respiratory and Critical Care Medicine

Volumn 187, Issue 10, 2013, Pages 1091-1097

  Annane, Djillali ^a   Timsit, Jean François ^b   Megarbane, Bruno ^c   Martin, Claude ^d   Misset, Benoit ^e   Mourvillier, Bruno ^f   Siami, Shidasp ^g   Chagnon, Jean Luc ^h   Constantin, Jean Michel ⁱ   Petitpas, Franck ^j   Souweine, Bertrand ^k   Amathieu, Roland ^l   Forceville, Xavier ^m   Charpentier, Claire ⁿ   Tesnier̀e, Antoine ^o   Chastre, Jean ^p   Bohe, Julien ^q   Colin, Gwenhael ^r   Cariou, Alain ^o   Renault, Alain ^s   Brun Buisson, Christian ^t   Bellissant, Eric ^s   more..

^a RAYMOND POINCARÉ HOSPITAL   (France)

^b GRENOBLE UNIVERSITY HOSPITAL   (France)

^c HÔPITAL LARIBOISIÈRE   (France)

^d HÔPITAL NORD   (France)

^e SAINT JOSEPH HOSPITAL   (France)

^f BICHAT HOSPITAL   (France)

^g Centre Hospitalier d'Etampes   (France)

^h CENTRE HOSPITALIER DE VALENCIENNES   (France)

ⁱ HÔTEL DIEU   (France)

^j POITIERS UNIVERSITY HOSPITAL   (France)

^k UNIVERSITY HOSPITAL OF CLERMONT FERRAND   (France)

^l HÔPITAL JEAN VERDIER   (France)

^m CENTRE HOSPITALIER DE MEAUX   (France)

ⁿ UNIVERSITY HOSPITAL OF NANCY   (France)

^o Hôpital Cochin ^*  (France)

^p PITIÉ SALPÊTRIÈRE HOSPITAL   (France)

^q CENTRE HOSPITALIER LYON SUD   (France)

^r CENTRE HOSPITALIER RENÉ DUBOS   (France)

^s RENNES UNIVERSITY HOSPITAL   (France)

^t HENRI MONDOR HOSPITAL   (France)

more..

Author keywords

Adjunct therapy; Anticoagulant; Clinical trial; Sepsis; Survival

Indexed keywords

D DIMER; DROTRECOGIN; FLUDROCORTISONE; HYDROCORTISONE;

ADULT; ARTICLE; ARTIFICIAL VENTILATION; BLEEDING; COMMUNICABLE DISEASE; COMORBIDITY; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; ERYTHROCYTE CONCENTRATE; FACTORIAL DESIGN; FEMALE; HOSPITAL DISCHARGE; HUMAN; INTENSIVE CARE UNIT; LENGTH OF STAY; LONG TERM CARE; MAJOR CLINICAL STUDY; MALE; MORTALITY; MULTICENTER STUDY; OUTCOME ASSESSMENT; PRIORITY JOURNAL; PROTHROMBIN TIME; RANDOMIZED CONTROLLED TRIAL; RENAL REPLACEMENT THERAPY; RISK BENEFIT ANALYSIS; SEPTIC SHOCK; SIDE EFFECT; STEROID THERAPY; SURVIVAL RATE; TIME TO TREATMENT;

ANTI-INFECTIVE AGENTS; ANTI-INFLAMMATORY AGENTS; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; FEMALE; FLUDROCORTISONE; HUMANS; HYDROCORTISONE; MALE; MIDDLE AGED; PROTEIN C; RECOMBINANT PROTEINS; SAFETY-BASED DRUG WITHDRAWALS; SHOCK, SEPTIC; TREATMENT OUTCOME;

EID: 84877891039     PISSN: 1073449X     EISSN: 15354970     Source Type: Journal    
DOI: 10.1164/rccm.201211-2020OC     Document Type: Article

References (23)

1. Annane D, Bellissant E, Cavaillon JM. Septic shock. Lancet 2005;365:63-78.
2. Bernard GR, Vincent JL, Laterre PF, LaRosa SP, Dhainaut JF, Lopez-Rodriguez A, Steingrub JS, Garber GE, Helterbrand JD, Ely EW, et al.; Recombinant Human Protein C Worldwide Evaluation in Severe Sepsis (PROWESS) Study Group. Efficacy and safety of recombinant human activated protein C for severe sepsis. N Engl J Med 2001;344:699-709.
3. Annane D. Adjunct therapy for sepsis: how early? Curr Infect Dis Rep 2010;12:361-367.
4. Ely EW, Laterre PF, Angus DC, Helterbrand JD, Levy H, Dhainaut JF, Vincent JL, Macias WL, Bernard GR; PROWESS Investigators. Drotrecogin alfa (activated) administration across clinically important subgroups of patients with severe sepsis. Crit Care Med 2003;31:12-19. (Pubitemid 36151143)
5. Levi M, van der Poll T. Recombinant human activated protein C: current insights into its mechanism of action. Crit Care 2007;11:S3.
6. Yuksel M, Okajima K, Uchiba M, Horiuchi S, Okabe H. Activated protein C inhibits lipopolysaccharide-induced tumor necrosis factor-α production by inhibiting activation of both nuclear factor-κB and activator protein-1 in human monocytes. Thromb Haemost 2002;88:267-273. (Pubitemid 34873708)
7. Cheng T, Liu D, Griffin JH, Fernández JA, Castellino F, Rosen ED, Fukudome K, Zlokovic BV. Activated protein C blocks p53-mediated apoptosis in ischemic human brain endothelium and is neuroprotective. Nat Med 2003;9:338-342. (Pubitemid 36362790)
8. Nadel S, Goldstein B, Williams MD, Dalton H, Peters M, Macias WL, Abd-Allah SA, Levy H, Angle R, Wang D, et al.; Researching Severe Sepsis and Organ Dysfunction in Children: a Global Perspective (RESOLVE) Study Group. Drotrecogin alfa (activated) in children with severe sepsis: a multicentre phase III randomised controlled trial. Lancet 2007;369:836-843. (Pubitemid 46365900)
9. Abraham E, Laterre PF, Garg R, Levy H, Talwar D, Trzaskoma BL, François B, Guy JS, Brückmann M, Rea-Neto A, et al.; Administration of Drotrecogin Alfa (Activated) in Early Stage Severe Sepsis (ADDRESS) Study Group. Drotrecogin alfa (activated) for adults with severe sepsis and a low risk of death. N Engl JMed 2005;353:1332-1341. (Pubitemid 41362701)
10. Dellinger RP, Levy MM, Carlet JM, Bion J, Parker MM, Jaeschke R, Reinhart K, Angus DC, Brun-Buisson C, Beale R, et al.; International Surviving Sepsis Campaign Guidelines Committee; American Association of Critical-Care Nurses; American College of Chest Physicians; American College of Emergency Physicians; Canadian Critical Care Society; European Society of Clinical Microbiology and Infectious Diseases; European Society of Intensive Care Medicine; European Respiratory Society; International Sepsis Forum; Japanese Association for Acute Medicine; Japanese Society of Intensive Care Medicine; Society of Critical Care Medicine; Society of Hospital Medicine; Surgical Infection Society; World Federation of Societies of Intensive and Critical Care Medicine. Surviving Sepsis Campaign: international guidelines for management of severe sepsis and septic shock: 2008. Crit Care Med 2008;36:296-327.
11. Martí-Carvajal AJ, Solà I, Lathyris D, Cardona AF. Human recombinant activated protein C for severe sepsis [review]. Cochrane Database Syst Rev 2012;3:CD004388.
12. Kalil AC, LaRosa SP. Effectiveness and safety of drotrecogin alfa (activated) for severe sepsis: a meta-analysis and metaregression. Lancet Infect Dis 2012;12:678-686.
13. Eli Lilly and Company. Lilly announces withdrawal of Xigris® following recent clinical trial results [accessed 2013 Feb]. Available from: http://newsroom.lilly.com/releasedetail.cfm?releaseid=617602
14. Ranieri VM, Thompson BT, Barie PS, Dhainaut JF, Douglas IS, Finfer S, Gårdlund B, Marshall JC, Rhodes A, Artigas A, et al.; PROWESS-SHOCK Study Group. Drotrecogin alfa (activated) in adults with septic shock. N Engl J Med 2012;366:2055-2064.
15. Vincent JL, Moreno R, Takala J, Willatts S, De Mendonça A, Bruining H, Reinhart CK, Suter PM, Thijs LG. The SOFA (Sepsis-related Organ Failure Assessment) score to describe organ dysfunction/failure. Intensive Care Med 1996;22:707-710. (Pubitemid 26254283)
16. Knaus WA, Zimmerman JE, Wagner DP, Draper EA, Lawrence DE. APACHE - Acute Physiology and Chronic Health Evaluation: a physiologically based classification system. Crit Care Med 1981;9:591-597.
17. McCabe WR, Jackson GG. Gram-negative bacteremia. I. Etiology and ecology. Arch Intern Med 1962;110:847-855.
18. Le Gall JR, Lemeshow S, Saulnier F. A new Simplified Acute Physiology Score (SAPS II) based on a European/North American multicenter study. JAMA 1993;270:2957-2963. (Pubitemid 24000804)
19. Moreno RP, Metnitz PG, Almeida E, Jordan B, Bauer P, Campos RA, Iapichino G, Edbrooke D, CapuzzoM, Le Gall JR; SAPS 3 Investigators. SAPS 3 - from evaluation of the patient to evaluation of the intensive care unit. 2 Development of a prognostic model for hospital mortality at ICU admission. Intensive Care Med 2005;31:1345-1355. (Pubitemid 41437728)
20. Mathieu J, De Braekeleer M, Prévost C, Boily C. Myotonic dystrophy: clinical assessment of muscular disability in an isolated population with presumed homogeneous mutation. Neurology 1992;42:203-208.
21. Annane D, Sébille V, Charpentier C, Bollaert PE, François B, Korach JM, Capellier G, Cohen Y, Azoulay E, Troch é G, et al. Effect of treatment with low doses of hydrocortisone and fludrocortisone on mortality in patients with septic shock. JAMA 2002;288:862-871.
22. Montori VM, Devereaux PJ, Adhikari NK, Burns KE, Eggert CH, Briel M, Lacchetti C, Leung TW, Darling E, Bryant DM, et al. Randomized trials stopped early for benefit: a systematic review. JAMA 2005;294:2203-2209. (Pubitemid 41571138)
23. Abraham E, Reinhart K, Opal S, Demeyer I, Doig C, Rodriguez AL, Beale R, Svoboda P, Laterre PF, Simon S, et al.; OPTIMIST Trial Study Group. Efficacy and safety of tifacogin (recombinant tissue factor pathway inhibitor) in severe sepsis: a randomized controlled trial. JAMA 2003;290:238-247. (Pubitemid 37430063)