Dexamethasone treatment for the acute respiratory distress syndrome: a multicentre, randomised controlled trial

The Lancet Respiratory Medicine

Volumn 8, Issue 3, 2020, Pages 267-276

  Villar, Jesús ^a,c,d,q   Ferrando, Carlos ^a,b,e,q   Martínez, Domingo ^f,q   Ambrós, Alfonso ^g,q   Muñoz, Tomás ^h,q   Soler, Juan A ^f,q   Aguilar, Gerardo ^e,q   Alba, Francisco ^i,q   González Higueras, Elena ^j,q   Conesa, Luís A ^f,q   Martín Rodríguez, Carmen ^g,q   Díaz Domínguez, Francisco J ^k,q   Serna Grande, Pablo ^h,q   Rivas, Rosana ^l,q   Ferreres, José ^e,q   Belda, Javier ^e,q   Capilla, Lucía ^m,n,q   Tallet, Alec ^o,q   Añón, José M ^a,p,q   Fernández, Rosa L ^a,c,q   González Martín, Jesús M ^c,q   Álvarez, Julián ^q   Asensio, María J ^q   Blanco, Jesús ^q   Blasco, Marisa ^q   Cachafeiro, Lucia ^q   del Campo, Rafael ^q   Carbonell, José A ^q   Carbonell, Nieves ^q   Cariñena, Agustín ^q   Carriedo, Demetrio ^q   Chico, Mario ^q   Corpas, Ruth ^q   Cuervo, Javier ^q   Domínguez Antelo, Cristina ^q   Fernández, Lorena ^q   Gamboa, Eneritz ^q   González Luengo, Raúl I ^q   Ortiz Díaz Miguel, Ramón ^q   Pérez González, Raquel ^q   Prieto, Ana M ^q   Prieto, Isidro ^q   Rojas Viguera, Leticia ^q   Romera, Miguel A ^q   Sánchez Ballesteros, Jesús ^q   Segura, José M ^q   Serrano, Ainhoa ^q   Solano, Rosario ^q   Soro, Marina ^q   more..

^a INSTITUTO DE SALUD CARLOS III   (Spain)

^b HOSPITAL CLÍNIC   (Spain)

^c HOSPITAL UNIVERSITARIO DE GRAN CANARIA DR NEGRÍN   (Spain)

^d ST MICHAEL'S HOSPITAL   (Canada)

^e HOSPITAL CLÍNICO UNIVERSITARIO   (Spain)

^f HOSPITAL UNIVERSITARIO VIRGEN DE LA ARRIXACA   (Spain)

^g HOSPITAL GENERAL UNIVERSITARIO DE CIUDAD REAL   (Spain)

^h HOSPITAL DE CRUCES   (Spain)

ⁱ HOSPITAL NUESTRA SEÑORA DEL PRADO   (Spain)

^j HOSPITAL VIRGEN DE LA LUZ   (Spain)

^k Complejo Asistencial Universitario de León   (Spain)

^l Hospital Galdakao Usansolo   (Spain)

^m HOSPITAL MORALES MESEGUER   (Spain)

ⁿ HOSPITAL GENERAL UNIVERSITARIO REINA SOFÍA   (Spain)

^o HOSPITAL GENERAL DE SEGOVIA   (Spain)

^p HOSPITAL UNIVERSITARIO LA PAZ   (Spain)

^q IdiPAZ ^*

more..

Author keywords

[No Author keywords available]

Indexed keywords

DEXAMETHASONE; GLUCOCORTICOID;

ADULT; ALL CAUSE MORTALITY; ARTERIAL OXYGEN TENSION; ARTICLE; ARTIFICIAL VENTILATION; CLINICAL EFFECTIVENESS; CONTROLLED STUDY; DISEASE SEVERITY; DOSE RESPONSE; DRUG DOSE REDUCTION; DRUG EFFECT; DRUG EFFICACY; FEMALE; FRACTION OF INSPIRED OXYGEN; HUMAN; INTENSIVE CARE UNIT; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; MORTALITY RATE; MULTICENTER STUDY; POSITIVE END EXPIRATORY PRESSURE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY DISTRESS; RESPIRATORY TRACT PARAMETERS; SPAIN; TEACHING HOSPITAL; TREATMENT OUTCOME; ADULT RESPIRATORY DISTRESS SYNDROME; ADVERSE EVENT; AGED; CLINICAL TRIAL; INTRAVENOUS DRUG ADMINISTRATION; MORTALITY; SEVERITY OF ILLNESS INDEX;

ADMINISTRATION, INTRAVENOUS; ADULT; AGED; DEXAMETHASONE; FEMALE; GLUCOCORTICOIDS; HUMANS; INTENSIVE CARE UNITS; MALE; MIDDLE AGED; RESPIRATION, ARTIFICIAL; RESPIRATORY DISTRESS SYNDROME, ADULT; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME;

EID: 85080050137     PISSN: 22132600     EISSN: 22132619     Source Type: Journal    
DOI: 10.1016/S2213-2600(19)30417-5     Document Type: Article

References (48)

1. Villar, J, Slutsky, AS, GOLDEN anniversary of the acute respiratory distress syndrome: still much work to do!. Curr Opin Crit Care 23 (2017), 4–9.
2. Brower, RG, Matthay, MA, Morris, A, Schoenfeld, D, Thompson, BT, Wheeler, A, Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med 342 (2000), 1301–1308.
3. Boyle, AJ, Mac Sweeney, R, McAuley, DF, Pharmacological treatments in ARDS; a state-of-the-art update. BMC Med, 11, 2013, 166.
4. Rhen, T, Cidlowski, JA, Anti-inflammatory action of glucocorticoids–new mechanisms for old drugs. N Engl J Med 353 (2005), 1711–1723.
5. Meduri, GU, Headley, AS, Golden, E, et al. Effect of prolonged methylprednisolone therapy in unresolving acute respiratory distress syndrome: a randomized controlled trial. JAMA 280 (1998), 159–165.
6. Steinberg, KP, Hudson, LD, Goodman, RB, et al. Efficacy and safety of corticosteroids for persistent acute respiratory distress syndrome. N Engl J Med 354 (2006), 1671–1684.
7. Annane, D, Sébille, V, Bellissant, E, Effect of low doses of corticosteroids in septic shock patients with or without early acute respiratory distress syndrome. Crit Care Med 34 (2006), 22–30.
8. Meduri, GU, Golden, E, Freire, AX, et al. Methylprednisolone infusion in early severe ARDS: results of a randomized controlled trial. Chest 131 (2007), 954–963.
9. Annane, D, Pastores, SM, Rochwerg, B, et al. Guidelines for the diagnosis and management of critical illness-related corticosteroid insufficiency (CIRCI) in critically ill patients (Part I): Society of Critical Care Medicine (SCCM) and European Society of Intensive Care Medicine (ESICM) 2017. Crit Care Med 45 (2017), 2078–2088.
10. Meijvis, SC, Hardeman, H, Remmelts, HH, et al. Dexamethasone and length of hospital stay in patients with community-acquired pneumonia: a randomised, double-blind, placebo-controlled trial. Lancet 377 (2011), 2023–2030.
11. Bernard, GR, Artigas, A, Brigham, KL, et al. The American-European Consensus Conference on ARDS. Definitions, mechanisms, relevant outcomes, and clinical trial coordination. Am J Respir Crit Care Med 149 (1994), 818–824.
12. Ranieri, VM, Rubenfeld, GD, Thompson, BT, et al. Acute respiratory distress syndrome: the Berlin Definition. JAMA 307 (2012), 2526–2533.
13. US Department of Health and Human Services from the Food and Drug Administration. Enrichment strategies for clinical trials to support determination of effectiveness of human drugs and biological products. Guidance for industry. https://www.fda.gov/media/121320/download, March 2019. (Accessed 8 May 2019)
14. Yehya, N, Harhay, MO, Curley, MAQ, Schoenfeld, DA, Reeder, RW, Re-appraisal of ventilator-free days in critical care research. Am J Respir Crit Care Med 200 (2019), 828–836.
15. Guérin, C, Reignier, J, Richard, JC, et al. Prone positioning in severe acute respiratory distress syndrome. N Engl J Med 368 (2013), 2159–2168.
16. The National Heart, Lung, and Blood Institute PETAL Clinical Trials Network. Early neuromuscular blockade in the acute respiratory distress syndrome. N Engl J Med 380 (2019), 1997–2008.
17. Villar, J, Belda, J, Añón, JM, et al. Evaluating the efficacy of dexamethasone in the treatment of patients with persistent acute respiratory distress syndrome: study protocol for a randomized controlled trial. Trials, 17, 2016, 342.
18. Villar, J, Pérez-Méndez, L, López, J, et al. An early PEEP/FIO2 trial identifies different degrees of lung injury in patients with acute respiratory distress syndrome. Am J Respir Crit Care Med 176 (2007), 795–804.
19. World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA 310 (2013), 2191–2194.
20. Azoulay, É, Canet, E, Raffoux, E, et al. Dexamethasone in patients with acute lung injury from acute monocytic leukaemia. Eur Respir J 39 (2012), 648–653.
21. Papazian, L, Doddoli, C, Chetaille, B, et al. A contributive result of open-lung biopsy improves survival in acute respiratory distress syndrome patients. Crit Care Med 35 (2007), 755–762.
22. Vincent, JL, Moreno, R, Takala, J, et al. The SOFA (Sepsis-related Organ Failure Assessment) score to describe organ dysfunction/failure. On behalf of the working group on sepsis-related problems of the european society of intensive care medicine. Intensive Care Med 22 (1996), 707–710.
23. Schoenfeld, DA, Bernard, GR, Statistical evaluation of ventilator-free days as an efficacy measure in clinical trials of treatments for acute respiratory distress syndrome. Crit Care Med 30 (2002), 1772–1777.
24. Villar, J, Blanco, J, Añón, JM, et al. The ALIEN study: incidence and outcome of acute respiratory distress syndrome in the era of lung protective ventilation. Intensive Care Med 37 (2011), 1932–1941.
25. Brun-Buisson, C, Minelli, C, Bertolini, G, et al. Epidemiology and outcome of acute lung injury in European intensive care units. Results from the ALIVE study. Intensive Care Med 30 (2004), 51–61.
26. Talmor, D, Sarge, T, Malhotra, A, et al. Mechanical ventilation guided by esophageal pressure in acute lung injury. N Engl J Med 359 (2008), 2095–2104.
27. Kacmarek, RM, Noninvasive respiratory support for post-extubation respiratory failure. Respir Care 64 (2019), 658–678.
28. Annane, D, Pastores, SM, Arlt, W, et al. Critical illness-related corticosteroid insufficiency (CIRCI): a narrative review from a multispecialty task force of the society of critical care medicine (SCCM) and the European Society of Intensive Care Medicine (ESICM). Crit Care Med 45 (2017), 2089–2098.
29. Meduri, GU, Annane, D, Chrousos, GP, Marik, PE, Sinclair, SE, Activation and regulation of systemic inflammation in ARDS: rationale for prolonged glucocorticoid therapy. Chest 136 (2009), 1631–1643.
30. Gerard, L, Bidoul, T, Castanares-Zapatero, D, et al. Open lung biopsy in nonresolving acute respiratory distress syndrome commonly identifies corticosteroid-sensitive pathologies, associated with better outcomes. Crit Care Med 46 (2018), 907–914.
31. Ashbaugh, DG, Bigelow, DB, Petty, TL, Levine, BE, Acute respiratory distress in adults. Lancet 2 (1967), 319–323.
32. Ashbaugh, DG, Maier, RV, Idiopathic pulmonary fibrosis in adult respiratory distress syndrome. Diagnosis and treatment. Arch Surg 120 (1985), 530–535.
33. Pastores, SM, Annane, D, Rochwerg, B, Guidelines for the diagnosis and management of critical illness-related corticosteroid insufficiency (CIRCI) in critically ill patients (Part II): Society of Critical Care Medicine (SCCM) and European Society of Intensive Care Medicine (ESICM) 2017. Intensive Care Med 44 (2018), 474–477.
34. Brouwer, MC, McIntyre, P, Prasad, K, van de Beek, D, Corticosteroids for acute bacterial meningitis. Cochrane Database Syst Rev, 6, 2013, CD004405.
35. Meduri, GU, Siemieniuk, RAC, Ness, RA, Seyler, SJ, Prolonged low-dose methylprednisolone treatment is highly effective in reducing duration of mechanical ventilation and mortality in patients with ARDS. J Intensive Care, 6, 2018, 53.
36. Maerz, LL, Akhtar, S, Perioperative glycemic management in 2011: paradigm shifts. Curr Opin Crit Care 17 (2011), 370–375.
37. Melby, JC, Clinical pharmacology of systemic corticosteroids. Annu Rev Pharmacol Toxicol 17 (1977), 511–527.
38. Burnham, EL, Janssen, WJ, Riches, DW, Moss, M, Downey, GP, The fibroproliferative response in acute respiratory distress syndrome: mechanisms and clinical significance. Eur Respir J 43 (2014), 276–285.
39. Bernard, GR, Vincent, JL, Laterre, PF, et al. Efficacy and safety of recombinant human activated protein C for severe sepsis. N Engl J Med 344 (2001), 699–709.
40. McKeever, T, Mortimer, K, Wilson, A, et al. Quadrupling inhaled glucocorticoid dose to abort asthma exacerbations. N Engl J Med 378 (2018), 902–910.
41. Zeuzem, S, Dusheiko, GM, Salupere, R, et al. Sofosbuvir and ribavirin in HCV genotypes 2 and 3. N Engl J Med 370 (2014), 1993–2001.
42. Ryan, CJ, Smith, MR, de Bono, JS, et al. Abiraterone in metastatic prostate cancer without previous chemotherapy. N Engl J Med 368 (2013), 138–148.
43. McCarthy, PL, Owzar, K, Hofmeister, CC, et al. Lenalidomide after stem-cell transplantation for multiple myeloma. N Engl J Med 366 (2012), 1770–1781.
44. Combes, A, Hajage, D, Capellier, G, et al. Extracorporeal membrane oxygenation for severe acute respiratory distress syndrome. N Engl J Med 378 (2018), 1965–1975.
45. Girardis, M, Busani, S, Damiani, E, et al. Effect of conservative vs. conventional oxygen therapy on mortality among patients in an intensive care unit. The oxygen-ICU randomized clinical trial. JAMA 316 (2016), 1583–1589.
46. National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network. Initial trophic vs full enteral feeding in patients with acute lung injury: the EDEN randomized trial. JAMA 307 (2012), 795–803.
47. Hébert, PC, Wells, G, Blajchman, MA, et al. A multicenter, randomized, controlled clinical trial of transfusion requirements in critical care. N Engl J Med 340 (1999), 409–417.
48. Wallis, CJD, Detsky, AS, Fan, E, Establishing the effectiveness of procedural interventions: the limited role of randomized trials. JAMA 320 (2018), 2421–2422.