Designing and conducting a randomized trial for pandemic critical illness: The 2009 H1N1 influenza pandemic

Intensive Care Medicine

Volumn 38, Issue 1, 2012, Pages 29-39

  Annane, Djillali ^a   Antona, Marion ^a   Lehmann, Blandine ^b   Kedzia, Cecile ^c   Chevret, Sylvie ^c  

^a RAYMOND POINCARÉ HOSPITAL   (France)

^b AGEPS   (France)

^c SAINT LOUIS HOSPITAL   (France)

Author keywords

Clinical trial; Critical illness; Design; Ethics; H1N1; Pandemic crisis

Indexed keywords

HYDROCORTISONE; PLACEBO; CORTICOSTEROID;

ARTICLE; ARTIFICIAL VENTILATION; CORTICOSTEROID THERAPY; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG SAFETY; EXTRACORPOREAL MEMBRANE OXYGENATION DEVICE; HEALTH STATUS; HUMAN; INFLUENZA A (H1N1); INTENSIVE CARE UNIT; LENGTH OF STAY; MEDICAL ETHICS; MORTALITY; MULTICENTER STUDY (TOPIC); PANDEMIC INFLUENZA; PHASE 3 CLINICAL TRIAL (TOPIC); RANDOMIZED CONTROLLED TRIAL (TOPIC); STUDY DESIGN; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CRITICAL ILLNESS; DOUBLE BLIND PROCEDURE; FEMALE; HOSPITALIZATION; INFLUENZA; INFLUENZA VIRUS A H1N1; MALE; METHODOLOGY; MULTICENTER STUDY; PHASE 3 CLINICAL TRIAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; RESEARCH ETHICS; VIROLOGY;

ADRENAL CORTEX HORMONES; CRITICAL ILLNESS; DOUBLE-BLIND METHOD; ETHICS, RESEARCH; FEMALE; HUMANS; INFLUENZA A VIRUS, H1N1 SUBTYPE; INFLUENZA, HUMAN; MALE; PROSPECTIVE STUDIES; RESEARCH DESIGN; SEVERITY OF ILLNESS INDEX;

EID: 84859934848     PISSN: 03424642     EISSN: 14321238     Source Type: Journal    
DOI: 10.1007/s00134-011-2409-8     Document Type: Article

References (23)

1. WHO (2009) Pandemic (H1N1) 2009-update 112. http://www.who.int/csr/don/ 2010-08-06/en/. Accessed 6 Aug 2009
2. Jain S, Kamimoto L, Bramley AM, Schmitz AM, Benoit SR, Louie J, Sugerman DE, Druckenmiller JK, Ritger KA, Chugh R, Jasuja S, Deutscher M, Chen S, Walker JD, Duchin JS, Lett S, Soliva S, Wells EV, Swerdlow D, Uyeki TM, Fiore AE, Olsen SJ, Fry AM, Bridges CB, Finelli L, 2009 Pandemic Influenza A (H1N1) Virus Hospitalizations Investigation Team (2009) Hospitalized patients with 2009 H1N1 influenza in the United States, April-June 2009. N Engl J Med 361:1935-1944
3. Bautista E, Chotpitayasunondh T, Gao Z, Harper SA, Shaw M, Uyeki TM, Zaki SR, Hayden FG, Hui DS, Kettner JD, Kumar A, Lim M, Shindo N, Penn C, Nicholson KG (2010) Clinical aspects of pandemic 2009 influenza A (H1N1) virus infection. N Engl J Med 362:1708-1719
4. de Jong MD, Simmons CP, Thanh TT, Hien VM, Smith GJ, Chau TN, Hoang DM, Chau NV, Khanh TH, Dong VC, Qui PT, Cam BV, Ha do Q, Guan Y, Peiris JS, Chinh NT, Hien TT, Farrar J (2006) Fatal outcome of human influenza A (H5N1) is associated with high viral load and hypercytokinemia. Nat Med 12:1203-1207
5. To KK, Hung IF, Li IW, Lee KL, Koo CK, Yan WW, Liu R, Ho KY, Chu KH, Watt CL, Luk WK, Lai KY, Chow FL, Mok T, Buckley T, Chan JF, Wong SS, Zheng B, Chen H, Lau CC, Tse H, Cheng VC, Chan KH, Yuen KY (2010) Delayed clearance of viral load and marked cytokine activation in severe cases of pandemic H1N1 2009 influenza virus infection. Clin Infect Dis 50:850-859
6. InFACT Global H1N1 Collaboration (2010) InFACT: a global critical care research response to H1N1. Lancet 375:11-13
7. Meduri GU, Marik PE, Chrousos GP, Pastores SM, Arlt W, Beishuizen A, Bokhari F, Zaloga G, Annane D (2008) Steroid treatment in ARDS: a critical appraisal of the ARDS network trial and the recent literature. Intensive Care Med 34:61-69
8. Lamontagne F, Briel M, Guyatt GH, Cook DJ, Bhatnagar N, Meade M (2010) Corticosteroid therapy for acute lung injury, acute respiratory distress syndrome, and severe pneumonia: a meta-Analysis of randomised controlled trials. J Crit Care 25:420-435
9. Domínguez-Cherit G, Lapinsky SE, Macias AE, Pinto R, Espinosa-Perez L, de la Torre A, Poblano-Morales M, Baltazar-Torres JA, Bautista E, Martinez A, Martinez MA, Rivero E, Valdez R, Ruiz-Palacios G, Hernández M, Stewart TE, Fowler RA (2009) Critically ill patients with 2009 influenza A(H1N1) in Mexico. JAMA 302:1880-1887
10. Kumar A, Zarychanski R, Pinto R, Cook DJ, Marshall J, Lacroix J, Stelfox T, Bagshaw S, Choong K, Lamontagne F, Turgeon AF, Lapinsky S, Ahern SP, Smith O, Siddiqui F, Jouvet P, Khwaja K, McIntyre L, Menon K, Hutchison J, Hornstein D, Joffe A, Lauzier F, Singh J, Karachi T, Wiebe K, Olafson K, Ramsey C, Sharma S, Dodek P, Meade M, Hall R, Fowler RA, Canadian Critical Care Trials Group H1N1 Collaborative (2009) Critically ill patients with 2009 influenza A(H1N1) infection in Canada. JAMA 302:1872-1879
11. Quispe-Laime AM, Bracco JD, Barberio PA, Campagne CG, Rolfo VE, Umberger R, Meduri GU (2010) H1N1 influenza A virus-Associated acute lung injury: response to combination oseltamivir and prolonged corticosteroid treatment. Intensive Care Med 36:33-41
12. Influenza Investigators ANZIC, Webb SA, Pettila V, Seppelt I, Bellomo R, Bailey M, Cooper DJ, Cretikos M, Davies AR, Finfer S, Harrigan PW, Hart GK, Howe B, Iredell JR, McArthur C, Mitchell I, Morrison S, Nichol AD, Paterson DL, Peake S, Richards B, Stephens D, Turner A, Yung M (2009) Critical care services and 2009 H1N1 influenza in Australia and New Zeland. N Engl J Med 361:1925-1934
13. Le Gall JR, Lemeshow S, Saulnier F (1993) A new Simplified Acute Physiology Score (SAPS II) based on a European/North American multicenter study. JAMA 270:2957-2963
14. Vincent JL, de Mendonça A, Cantraine F, Moreno R, Takala J, Suter PM, Sprung CL, Colardyn F, Blecher S (1998) Use of the SOFA score to assess the incidence of organ dysfunction/failure in intensive care units: results of a multicenter, prospective study. Crit Care Med 26:1793-1800
15. Resche-Rigon M, Azoulay E, Chevret S (2006) Evaluating mortality in intensive care units: contribution of competing risks analyses. Crit Care 10:R5
16. Annane D, Vignon P, Renault A, Bollaert PE, Charpentier C, Martin C, Troché G, Ricard JD, Nitenberg G, Papazian L, Azoulay E, Bellissant E, CATS Study Group (2007) Norepinephrine plus dobutamine versus epinephrine alone for management of septic shock: a randomised trial. Lancet 370:676-684
17. COIITSS Study Investigators (2010) Corticosteroid treatment and intensive insulin therapy for septic shock in adults: a randomised controlled trial. JAMA 303(4):341-348
18. Schulz KF, Grimes DA (2002) Blinding in randomised trials: hiding who got what. Lancet 359:696-700
19. Psaty BM, Prentice RL (2010) Minimizing bias in randomised trials: the importance of blinding. JAMA 304:793-794
20. Steinberg KP, Hudson LD, Goodman RB, Hough CL, Lanken PN, Hyzy R, Thompson BT, Ancukiewicz M, National Heart Blood Lung Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network (2006) Efficacy and safety of corticosteroids for persistent acute respiratory distress syndrome. N Engl J Med 354:1671-1684
21. Canini L, Andre'oletti L, Ferrari P, D'Angelo R, Blanchon T, Lemaitre M, Filleul L, Ferry JP, Desmaizieres M, Smadja S, Valleron AJ, Carrat F (2010) Surgical mask to prevent influenza transmission in households: a cluster randomised trial. PLoS One 5:e13998
22. Parmar MK, Griffiths GO, Spiegelhalter DJ, Souhami RL, Altman DG, van der Scheuren E, CHART steering committee (2001) Monitoring of large randomised clinical trials: a new approach with Bayesian methods. Lancet 358:375-381
23. Orloff JJ, Stanski D (2011) Innovative approaches to clinical development and trial design. Ann Ist Super Sanita 47:8-13