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1. Rationale, study design, and analysis plan of the Alveolar Recruitment for ARDS Trial (ART): study protocol for a randomized controlled trial

Author

Cavalcanti, AB, Berwanger, O, Suzumura, ÉA, Amato, MB, Tallo, FS, Rezende, AC, Telles, MM, Romano, E, Guimarães, HP, Regenga, MM, Takahashi, LN, Oliveira, RP, Carvalho, VO, Díaz Quijano, FA, Carvalho, CR, Kodama, AA, Ribeiro, GF, Abreu, MO, Oliveira, IM, Guyatt, G, Ferguson, N, Walter, S, Vasconcelos, MO, Segundo, VJ, Ferraz, ÍL, Silva, RS, de Oliveira Filho, W, Silva, NB, Heirel, C, Takatani, RR, Neto, JA, Neto, JC, Almeida, SD, Chamy, G, Neto, GJ, Dias, AP, Silva, RR, Tavares, RC, Souza, ML, Decio, JC, Lima, CM, Neto, FF, Oliveira, KR, Dias, PP, Brandão, AL, Ramos, JE Jr, Vasconcelos, PT, Flôres, DG, Filho, GR, Andrade, IG, Martinez, A, França, GG, Monteiro, LL, Correia, EI, Ribeiro, W, Pereira, AJ, Andrade, W, Leite, PA, Feto, JE, Holanda, MA, Amorim, FF, Margalho, SB, Domingues, SM Jr, Ferreira, CS, Ferreira, CM, Rabelo, LA, Duarte, JN, Lima, FB, Kawaguchi, IA, Maia, MO, Correa, FG, Ribeiro, RA, Caser, E, Moreira, CL, Marcilino, A, Falcão, JG, Jesus, KR, Tcherniakovisk, L, Dutra, VG, Thompson, MM, Piras, C, Giuberti, J. Jr, Silva, AS, Santos, JR, Potratz, JL, Paula, LN, Bozi, GG, Gomes, BC, Vassallo, PF, Rocha, E, Lima, MH, Ferreira, A. F, Gonçalves, F, Pereira, SA, Nobrega, MS, Caixeta, CR, Moraes, AP, Carvalho, AG, Alves, JD, Carvalho, FB, Moreira, FB, Starling, CM, Couto, WA, Bitencourt, WS, Silva, SG, Felizardo, LR, Nascimento, FJ, Santos, D, Zanta, CC, Martins, MF, Naves, SA, Silva, FD, Laube, G. Jr, Galvão, EL, Sousa, MF, Souza, MM, Carvalho, FL, Bergo, RR, Rezende, CM, Tamazato, EY, Sarat, SC Jr, Almeida, PS, Gorski, AG, Matsui, M, Neto, EE, Nomoto, SH, Lima, ZB, Inagaki, AS, Gil, FS, Araújo, MF, Oliveira, AE, Correa, TA, Mendonça, A, Reis, H, Carneiro, SR, Rego, LR, Cunha, AF, Barra, WF, Carneiro, M, Batista, RA, Zoghbi, KK, Machado, NJ, Ferreira, R, Apoena, P, Leão, RM, Martins, ER, Oliveira, ME, Odir, I, Kleber, W, Tavares, D, Araújo, ME, Brilhante, YN, Tavares, DC, Carvalho, WL, Winveler, GF, Filho, AC, Cavalcanti, RA, Grion, CM, Reis, AT, Festti, J, Gimenez, FM, Larangeira, AS, Cardoso, LT, Mezzaroba, TS, Kauss, IA, Duarte, PA, Tozo, TC, Peliser, P, Germano, A, Gurgel, SJ, Silva, SR, Kuroda, CM, Herek, A, Yamada, SS, Schiavetto, PM, Wysocki, N, Matsubara, RR, Sales, JA Jr, Laprovita, MP, Pena, FM, Sá, A, Vianna, A, Verdeal, JC, Martins, GA, Salgado, DR, Coelho, AM, Coelho, M, Morong, AS, Poquiriqui, RM, Ferreira, AP, Lucena, DN, Marino, NF, Moreira, MA, Uratani, CC, Severino, MA, Silva, PN, Medeiros, LG, Filho, FG, Guimarães, DM, Rezende, VM, Carbonell, RC, Trindade, RS, Pellegrini, JA, Boniatti, MM, Santos, MC, Boldo, R, Oliveira, VM, Corrêa, VM, Nedel, W, Teixeira, C, Schaich, F, Tagliari, L, Savi, A, Schulz, LF, Maccari, JG, Seeger, GM, Foernges, RB, Rieder, MM, Becker, DA, Broilo, FP, Schwarz, P, Alencastro, A, Berto, P, Backes, F, Dias, FS, Blattner, C, Martins, ET, Scaglia, NC, Vieira, SR, Prado, KF, Fialkow, L, Franke, C, Vieira, DF, Moraes, RB, Marques, LS, Hopf, JL, Wawrzeniak, IC, Rech, TH, Albuquerque, RB, Guerreiro, MO, Teixeira, LO, Macedo, PL, Bainy, MP, Ferreira, EV, Martins, MA, Andrade, LA, Machado, FO, Burigo, AC, Pincelli, M, Kretzer, L, Maia, IS, Cordeiro, RB, Westphal, G, Cramer, AS, Dadam, MM, Barbosa, PO, Caldeira, M, Brilenger, CO, Horner, MB, Oliveira, GL, Germiniani, BC, Duarte, R, Assef, MG, Rosso, D, Bigolin, R, Vanzuita, R, Prado, LF, Oliveira, V, Reis, DL, Morais, MO, Bastos, RS, Santana, HS, Silva, AO, Cacau, LA, Almeida, MS, Canavessi, HS, Nogueira, EE, Pavia, CL, Araujo, JF, Lira, JA, Nienstedt, EC, Smith, TC, Romano, M, Barros D, Costa, AF, Takahashi, L, Werneck, V, Farran, J, Henriques, LA, Miura, C, Lopes, RD, Vendrame, LS, Sandri, P, Galassi, MS, Amato, P, Toufen, C. Jr, Santiago, RR, Hirota, AS, Park, M, Azevedo, LC, Malbouison, LM, Costa, MC, Taniguchi, L, Pompílio, CE, Baruzzi, C, Andrade, AH, Taira, EE, Taino, B, Oliveira, CS, Silva, AC, Ísola, A, Rezende, E, Rodrigues, RG, Rangel, VP, Luzzi, S, Giacomassi, IW, Nassar, AP Jr, Souza, AR, Rahal, L, Nunes, AL, Giannini, F, Menescal, B, Morais, JE, Toledo, D, Morsch, RD, Merluzzi, T, Amorim, DS, Bastos, AC, Santos, PL, Silva, SF, Gallego, RC, Santos, GD, Tucci, M, Costa, RT, Santos, LS, Demarzo, SE, Schettino, GP, Suzuki, VC, Patrocinio, AC, Martins, ML, Passos, DB, Cappi, SB, Gonçalves, I. Jr, Borges, MC, Lovato, W, Tavares, MV, Morales, D, Machado, LA, Torres, FC, Gomes, TM, Cerantola, RB, Góis, A, Marraccini, T, Margarida, K, Cavalcante, E, Machado, FR, Mazza, BF, Santana, HB, Mendez, VM, Xavier, PA, Rabelo, MV, Schievano, FR, Pinto, WA, Francisco, RS, Ferreira, EM, Silva, DC, Arduini, RG, Aldrighi, JR, Amaro, AF, Conde, KA, Pereira, CA, Tarkieltaub, E, Oliver, WR, Guadalupe, EG, Acerbi, PS, Tomizuka, CI, Oliveira, TA, Geha, NN, Mecatti, GC, Piovesan, MZ, Salomão, MC, Moreno, MS, Orsatti, VN, Miranda, W, Ray, A, Guerra, A, Filho, ML, Ferreira, FH Jr, Filho, EV, Canzi, RA, Giuberti, AF, Garcez, MC, Sala, AD, Suguitani, EO, Kazue, P, Oliveira, LR, Infantini, RM, Carvalho, FR, Andrade, LC, Santos, TM, Carmona, CV, Figueiredo, LC, Falcão, A, Dragosavak, D, Filho, WN, Lunardi, MC, Lago, R, Gatti, C, Chiasso, TM, Santos, GO, Araujo, AC, Ornellas, IB, Vieira, VM, Hajjar, LA, Figueiredo, AC, Damasceno, B, Hinestrosa, A, Diaz Quijano, FA, CORTEGIANI, Andrea, RAINERI, Santi Maurizio, Cavalcanti, AB, Berwanger, O, Suzumura, ÉA, Amato, MB, Tallo, FS, Rezende, AC, Telles, MM, Romano, E, Guimarães, HP, Regenga, MM, Takahashi, LN, Oliveira, RP, Carvalho, VO, Díaz-Quijano, FA, Carvalho, CR, Kodama, AA, Ribeiro, GF, Abreu, MO, Oliveira, IM, Guyatt, G, Ferguson, N, Walter, S, Vasconcelos, MO, Segundo, VJ, Ferraz, ÍL, Silva, RS, de Oliveira Filho, W, Silva, NB, Heirel, C, Takatani, RR, Neto, JA, Neto, JC, Almeida, SD, Chamy, G, Neto, GJ, Dias, AP, Silva, RR, Tavares, RC, Souza, ML, Decio, JC, Lima, CM, Neto, FF, Oliveira, KR, Dias, PP, Brandão, AL, Ramos, JE Jr, Vasconcelos, PT, Flôres, DG, Filho, GR, Andrade, IG, Martinez, A, França, GG, Monteiro, LL, Correia, EI, Ribeiro, W, Pereira, AJ, Andrade, W, Leite, PA, Feto, JE, Holanda, MA, Amorim, FF, Margalho, SB, Domingues, SM Jr, Ferreira, CS, Ferreira, CM, Rabelo, LA, Duarte, JN, Lima, FB, Kawaguchi, IA, Maia, MO, Correa, FG, Ribeiro, RA, Caser, E, Moreira, CL, Marcilino, A, Falcão, JG, Jesus, KR, Tcherniakovisk, L, Dutra, VG, Thompson, MM, Piras, C, Giuberti, J Jr, Silva, AS, Santos, JR, Potratz, JL, Paula, LN, Bozi, GG, Gomes, BC, Vassallo, PF, Rocha, E, Lima, MH, Ferreira, A F, Gonçalves, F, Pereira, SA, Nobrega, MS, Caixeta, CR, Moraes, AP, Carvalho, AG, Alves, JD, Carvalho, FB, Moreira, FB, Starling, CM, Couto, WA, Bitencourt, WS, Silva, SG, Felizardo, LR, Nascimento, FJ, Santos, D, Zanta, CC, Martins, MF, Naves, SA, Silva, FD, Laube, G Jr, Galvão, EL, Sousa, MF, Souza, MM, Carvalho, FL, Bergo, RR, Rezende, CM, Tamazato, EY, Sarat, SC Jr, Almeida, PS, Gorski, AG, Matsui, M, Neto, EE, Nomoto, SH, Lima, ZB, Inagaki, AS, Gil, FS, Araújo, MF, Oliveira, AE, Correa, TA, Mendonça, A, Reis, H, Carneiro, SR, Rego, LR, Cunha, AF, Barra, WF, Carneiro, M, Batista, RA, Zoghbi, KK, Machado, NJ, Ferreira, R, Apoena, P, Leão, RM, Martins, ER, Oliveira, ME, Odir, I, Kleber, W, Tavares, D, Araújo, ME, Brilhante, YN, Tavares, DC, Carvalho, WL, Winveler, GF, Filho, AC, Cavalcanti, RA, Grion, CM, Reis, AT, Festti, J, Gimenez, FM, Larangeira, AS, Cardoso, LT, Mezzaroba, TS, Kauss, IA, Duarte, PA, Tozo, TC, Peliser, P, Germano, A, Gurgel, SJ, Silva, SR, Kuroda, CM, Herek, A, Yamada, SS, Schiavetto, PM, Wysocki, N, Matsubara, RR, Sales, JA Jr, Laprovita, MP, Pena, FM, Sá, A, Vianna, A, Verdeal, JC, Martins, GA, Salgado, DR, Coelho, AM, Coelho, M, Morong, AS, Poquiriqui, RM, Ferreira, AP, Lucena, DN, Marino, NF, Moreira, MA, Uratani, CC, Severino, MA, Silva, PN, Medeiros, LG, Filho, FG, Guimarães, DM, Rezende, VM, Carbonell, RC, Trindade, RS, Pellegrini, JA, Boniatti, MM, Santos, MC, Boldo, R, Oliveira, VM, Corrêa, VM, Nedel, W, Teixeira, C, Schaich, F, Tagliari, L, Savi, A, Schulz, LF, Maccari, JG, Seeger, GM, Foernges, RB, Rieder, MM, Becker, DA, Broilo, FP, Schwarz, P, Alencastro, A, Berto, P, Backes, F, Dias, FS, Blattner, C, Martins, ET, Scaglia, NC, Vieira, SR, Prado, KF, Fialkow, L, Franke, C, Vieira, DF, Moraes, RB, Marques, LS, Hopf, JL, Wawrzeniak, IC, Rech, TH, Albuquerque, RB, Guerreiro, MO, Teixeira, LO, Macedo, PL, Bainy, MP, Ferreira, EV, Martins, MA, Andrade, LA, Machado, FO, Burigo, AC, Pincelli, M, Kretzer, L, Maia, IS, Cordeiro, RB, Westphal, G, Cramer, AS, Dadam, MM, Barbosa, PO, Caldeira, M, Brilenger, CO, Horner, MB, Oliveira, GL, Germiniani, BC, Duarte, R, Assef, MG, Rosso, D, Bigolin, R, Vanzuita, R, Prado, LF, Oliveira, V, Reis, DL, Morais, MO, Bastos, RS, Santana, HS, Silva, AO, Cacau, LA, Almeida, MS, Canavessi, HS, Nogueira, EE, Pavia, CL, Araujo, JF, Lira, JA, Nienstedt, EC, Smith, TC, Romano, M, Barros D, Costa, AF, Takahashi, L, Werneck, V, Farran, J, Henriques, LA, Miura, C, Lopes, RD, Vendrame, LS, Sandri, P, Galassi, MS, Amato, P, Toufen, C Jr, Santiago, RR, Hirota, AS, Park, M, Azevedo, LC, Malbouison, LM, Costa, MC, Taniguchi, L, Pompílio, CE, Baruzzi, C, Andrade, AH, Taira, EE, Taino, B, Oliveira, CS, Silva, AC, Ísola, A, Rezende, E, Rodrigues, RG, Rangel, VP, Luzzi, S, Giacomassi, IW, Nassar, AP Jr, Souza, AR, Rahal, L, Nunes, AL, Giannini, F, Menescal, B, Morais, JE, Toledo, D, Morsch, RD, Merluzzi, T, Amorim, DS, Bastos, AC, Santos, PL, Silva, SF, Gallego, RC, Santos, GD, Tucci, M, Costa, RT, Santos, LS, Demarzo, SE, Schettino, GP, Suzuki, VC, Patrocinio, AC, Martins, ML, Passos, DB, Cappi, SB, Gonçalves, I Jr, Borges, MC, Lovato, W, Tavares, MV, Morales, D, Machado, LA, Torres, FC, Gomes, TM, Cerantola, RB, Góis, A, Marraccini, T, Margarida, K, Cavalcante, E, Machado, FR, Mazza, BF, Santana, HB, Mendez, VM, Xavier, PA, Rabelo, MV, Schievano, FR, Pinto, WA, Francisco, RS, Ferreira, EM, Silva, DC, Arduini, RG, Aldrighi, JR, Amaro, AF, Conde, KA, Pereira, CA, Tarkieltaub, E, Oliver, WR, Guadalupe, EG, Acerbi, PS, Tomizuka, CI, Oliveira, TA, Geha, NN, Mecatti, GC, Piovesan, MZ, Salomão, MC, Moreno, MS, Orsatti, VN, Miranda, W, Ray, A, Guerra, A, Filho, ML, Ferreira, FH Jr, Filho, EV, Canzi, RA, Giuberti, AF, Garcez, MC, Sala, AD, Suguitani, EO, Kazue, P, Oliveira, LR, Infantini, RM, Carvalho, FR, Andrade, LC, Santos, TM, Carmona, CV, Figueiredo, LC, Falcão, A, Dragosavak, D, Filho, WN, Lunardi, MC, Lago, R, Gatti, C, Chiasso, TM, Santos, GO, Araujo, AC, Ornellas, IB, Vieira, VM, Hajjar, LA, Figueiredo, AC, Damasceno, B, Hinestrosa, A, Diaz-Quijano, FA, Raineri, SM, and Cortegiani, A

Subjects
Research design, ARDS, medicine.medical_specialty, Time Factors, Ventilator-Induced Lung Injury, Alveolar recruitment, Treatment outcome, Randomized, Medicine (miscellaneous), Settore MED/41 - Anestesiologia, Hospital mortality, law.invention, Positive-Pressure Respiration, Study Protocol, Mechanical ventilation, Clinical trials, Randomized controlled trial, Clinical Protocols, law, Medicine, Humans, Pharmacology (medical), Hospital Mortality, PEEP, Protocol (science), Respiratory Distress Syndrome, Acute respiratory distress syndrome, business.industry, respiratory system, Length of Stay, medicine.disease, Clinical trial, Pulmonary Alveoli, Intensive Care Units, Treatment Outcome, Multicenter study, Barotrauma, Research Design, Physical therapy, business, Brazil
Abstract

Background Acute respiratory distress syndrome (ARDS) is associated with high in-hospital mortality. Alveolar recruitment followed by ventilation at optimal titrated PEEP may reduce ventilator-induced lung injury and improve oxygenation in patients with ARDS, but the effects on mortality and other clinical outcomes remain unknown. This article reports the rationale, study design, and analysis plan of the Alveolar Recruitment for ARDS Trial (ART). Methods/Design ART is a pragmatic, multicenter, randomized (concealed), controlled trial, which aims to determine if maximum stepwise alveolar recruitment associated with PEEP titration is able to increase 28-day survival in patients with ARDS compared to conventional treatment (ARDSNet strategy). We will enroll adult patients with ARDS of less than 72 h duration. The intervention group will receive an alveolar recruitment maneuver, with stepwise increases of PEEP achieving 45 cmH2O and peak pressure of 60 cmH2O, followed by ventilation with optimal PEEP titrated according to the static compliance of the respiratory system. In the control group, mechanical ventilation will follow a conventional protocol (ARDSNet). In both groups, we will use controlled volume mode with low tidal volumes (4 to 6 mL/kg of predicted body weight) and targeting plateau pressure ≤30 cmH2O. The primary outcome is 28-day survival, and the secondary outcomes are: length of ICU stay; length of hospital stay; pneumothorax requiring chest tube during first 7 days; barotrauma during first 7 days; mechanical ventilation-free days from days 1 to 28; ICU, in-hospital, and 6-month survival. ART is an event-guided trial planned to last until 520 events (deaths within 28 days) are observed. These events allow detection of a hazard ratio of 0.75, with 90% power and two-tailed type I error of 5%. All analysis will follow the intention-to-treat principle. Discussion If the ART strategy with maximum recruitment and PEEP titration improves 28-day survival, this will represent a notable advance to the care of ARDS patients. Conversely, if the ART strategy is similar or inferior to the current evidence-based strategy (ARDSNet), this should also change current practice as many institutions routinely employ recruitment maneuvers and set PEEP levels according to some titration method. Trial registration ClinicalTrials.gov Identifier: NCT01374022

Published
2012

2. Aspirin in Patients Undergoing Noncardiac Surgery

Author

Devereaux, Pj, Mrkobrada, M, Sessler, Di, Leslie, K, Alonso Coello, P, Kurz, A, Villar, Jc, Sigamani, A, Biccard, Bm, Meyhoff, Cs, Parlow, Jl, Guyatt, G, Robinson, A, Garg, Ax, Rodseth, Rn, Botto, F, Lurati Buse, G, Xavier, D, Chan, Mt, Tiboni, M, Cook, D, Kumar, Pa, Forget, P, Malaga, G, Fleischmann, E, Amir, M, Eikelboom, J, Mizera, R, Torres, D, Wang, Cy, Vanhelder, T, Paniagua, P, Berwanger, O, Srinathan, S, Graham, M, Pasin, L, Le Manach, Y, Gao, P, Pogue, J, Whitlock, R, Lamy, A, Kearon, C, Baigent, C, Chow, C, Pettit, S, Chrolavicius, S, Yusuf, S, DeBeer J, POISE 2 I. n. v. e. s. t. i. g. a. t. o. r. s., Patel, A, Dechert, W, Jackson, P, Allard, R, Dumerton Shore, D, Mccourt, J, Jones, Pm, Lavi, R, Lavi, S, Moor, R, Dresser, Gk, Gros, Ml, Schumann, Vc, Baur, M, Macdonald, C, Wirzba, B, Regalado, O, Srinathan, Sk, Ong, Dd, Todd, A, Abbas, S, Beattie, Ws, Chan, Vw, Chin, Kj, Wijeysundera, Dn, Graham, Mm, Irwin, M, Jacka, M, El Beheiry, H, Mcmullen, Sm, Macdonald, P, Akhtar, Z, Ayad, S, Buttar, M, Deroee, A, Eshraghi, Y, Fergany, A, Finnigan, P, Fu, A, Grady, M, Helper, S, Hesler, B, Honar, H, Hutcherson, M, Krebs, V, Lee, J, Malik, M, Podolyak, A, Salmasi, V, Arora, H, Coombs, Rf, Martinelli, Sm, Bergese, Sd, Melibary, Sb, Uribe, Aa, Jordan, M, Miller, Sa, Cata, Jp, Nemergut, Ec, Candiotti, Ka, Memtsoudis, Sg, Mckay, Re, Montes, Fr, Parra, Ga, Rojas, Mf, Plata, R, Vásquez, Sm, Sarquis, T, Haider, Z, Jane, Nb, Lanjewar, Pp, Rahate, Pv, Mehra, Br, Premendaran, B, Abraham, V, George, P, Kumar, P, Gaikwad, Sb, Mohan, Nv, Sidhu, G, Alvarez, J, Gonzalez, R, Maestre, M, Popova, E, Urrutia, G, de Nadal, M, González Suárez, S, González Tallada, A, Plou, P, Mena, E, Riveira, C, del Valle, S, Tena, B, Lang, Sa, Ludbrook, Gl, Painter, Tw, Terblanche, Nc, Osborne, C, Mahood, Jr, Myles, Ps, Sivalingam, P, Riedel, B, Elhalawani, I, Drummond, L, Mugabi, A, Naidoo, P, Myburgh, Al, Porrill, Os, Diedericks, Bj, Turton, Ew, Bøgeskov, M, Dahl, Rm, Madsen, Mv, Søndergaard, Es, Bauer, Ne, Martinsen, Kr, Choi, Gy, Gin, T, Ng, Ss, Bidgoli, Sj, Van der Linden PJ, De Kock, M, Kabon, B, Luf, F, Radonic, M, Ishtiaq, O, Safdar, J, Acuna Villaorduna, A, Barrionuevo, P, Castaneda Guarderas, A, Caballero, Ja, Lau, Ve, Aphang Lam MR, Lembo, R, Gossetti, Bruno, Jara, X, Leon, P, Ong, Gs, Lee, Hs, Seeberger, Ee, Seeberger, Md, Alfonsi, P, Coriat, P, Piriou, V, Vizcaychipi, Mp, Rech, Rl, Bergo, Rr, Walker, S, Rodseth, R, Lemanach, Y, Díaz, R, Cortés, Ol, Wetterslev, J, Hoeft, A, Wittmann, M, Chan, M, Landoni, G, Conen, D, Balaji, P, Sovereign, T, Blake, L, Sephton, J, Serra, A, Agrippa, C, Lawrence, M, Biccard, B, Gluud, C, Karthikeyan, G, Auerbach, A, Beattie, S, Buckley, N, Douketis, J, Gerstein, H, Ghali, W, Hart, R, Hill, M, Mcalister, F, Mcauley, D, Miller, S, O'Donnell, M, Pais, P, Parlow, J, Schricker, T, Sessler, D, Simunovic, M, Teoh, K, Walsh, M, Wijeysundera, D, Yang, H, Alshalash, S, Bessissow, A, Duceppe, E, Khalid, Z, Khan, J, Lauw, M, Martinsen, K, Neary, J, Oczkowski, W, Papina, M, Seeberger, M, Tandon, V, Thomas, S, Friedman, L, Cheng, D, Johnstone, D, Lowenstein, E, Roberts, R., Devereaux, Pj, Mrkobrada, M, Sessler, Di, Leslie, K, Alonso Coello, P, Kurz, A, Villar, Jc, Sigamani, A, Biccard, Bm, Meyhoff, C, Parlow, Jl, Guyatt, G, Robinson, A, Garg, Ax, Rodseth, Rn, Botto, F, Lurati Buse, G, Xavier, D, Chan, Mt, Tiboni, M, Cook, D, Kumar, Pa, Forget, P, Malaga, G, Fleischmann, E, Amir M, Eikelboom J, Mizera, R, Torres, D, Wang, Cy, Vanhelder, T, Paniagua, P, Berwanger, O, Srinathan, S, Graham, M, Pasin, L, Le Manach, Y, Gao, P, Pogue, J, Whitlock, R, Lamy, A, Kearon, C, Baigent, C, Chow, C, Pettit, S, Chrolavicius, S, Yusuf, S, and Landoni, Giovanni

Subjects
Male, Myocardial Infarction, Kaplan-Meier Estimate, noncardiac surgery, postoperative period, law.invention, low drug dose, hazard ratio, Postoperative Complications, Randomized controlled trial, law, Myocardial infarction, Treatment Failure, Aspirin, Medicine (all), Hazard ratio, drug effect, article, risk assessment, General Medicine, Middle Aged, female, priority journal, Anesthesia, drug withdrawal, factorial design, Surgical Procedures, Operative, Platelet aggregation inhibitor, Female, medicine.drug, hospitalization, heart infarction, perioperative period, preoperative treatment, Postoperative Hemorrhage, Perioperative Care, length of stay, death, medicine, Humans, follow up, controlled study, human, clonidine, outcome assessment, Aged, treatment duration, Vascular disease, business.industry, Platelet Aggregation Inhibitor, patient care, acetylsalicylic acid, medicine.disease, bleeding, major clinical study, Confidence interval, purl.org/pe-repo/ocde/ford#3.02.00 [https], Clinical research, multicenter study, randomized controlled trial, placebo, Postoperative Complication, business, Platelet Aggregation Inhibitors
Abstract

BACKGROUND: There is substantial variability in the perioperative administration of aspirin in patients undergoing noncardiac surgery, both among patients who are already on an aspirin regimen and among those who are not. METHODS: Using a 2-by-2 factorial trial design, we randomly assigned 10,010 patients who were preparing to undergo noncardiac surgery and were at risk for vascular complications to receive aspirin or placebo and clonidine or placebo. The results of the aspirin trial are reported here. The patients were stratified according to whether they had not been taking aspirin before the study (initiation stratum, with 5628 patients) or they were already on an aspirin regimen (continuation stratum, with 4382 patients). Patients started taking aspirin (at a dose of 200 mg) or placebo just before surgery and continued it daily (at a dose of 100 mg) for 30 days in the initiation stratum and for 7 days in the continuation stratum, after which patients resumed their regular aspirin regimen. The primary outcome was a composite of death or nonfatal myocardial infarction at 30 days. RESULTS: The primary outcome occurred in 351 of 4998 patients (7.0%) in the aspirin group and in 355 of 5012 patients (7.1%) in the placebo group (hazard ratio in the aspirin group, 0.99; 95% confidence interval [CI], 0.86 to 1.15; P = 0.92). Major bleeding was more common in the aspirin group than in the placebo group (230 patients [4.6%] vs. 188 patients [3.8%]; hazard ratio, 1.23; 95% CI, 1.01, to 1.49; P = 0.04). The primary and secondary outcome results were similar in the two aspirin strata. CONCLUSIONS: Administration of aspirin before surgery and throughout the early postsurgical period had no significant effect on the rate of a composite of death or nonfatal myocardial infarction but increased the risk of major bleeding. (Funded by the Canadian Institutes of Health Research and others; POISE-2 ClinicalTrials.gov number, NCT01082874.) Copyright © 2014 Massachusetts Medical Society.

Published
2014

3. Clonidine in patients undergoing noncardiac surgery

Author

Devereaux, Pj, Sessler, Di, Leslie, K, Kurz, A, Mrkobrada, M, Alonso Coello, P, Villar, Jc, Sigamani, A, Biccard, Bm, Meyhoff, Cs, Parlow, Jl, Guyatt, G, Robinson, A, Garg, Ax, Rodseth, Rn, Botto, F, Lurati Buse, G, Xavier, D, Chan, Mt, Tiboni, M, Cook, D, Kumar, Pa, Forget, P, Malaga, G, Fleischmann, E, Amir, M, Eikelboom, J, Mizera, R, Torres, D, Wang, Cy, Vanhelder, T, Paniagua, P, Berwanger, O, Srinathan, S, Graham, M, Pasin, L, Le Manach, Y, Gao, P, Pogue, J, Whitlock, R, Lamy, A, Kearon, C, Chow, C, Pettit, S, Chrolavicius, S, Yusuf, S, Debeer, J, Patel, A, Dechert, W, Jackson, P, Allard, R, Dumerton Shore, D, Mccourt, J, Jones, Pm, Lavi, R, Lavi, S, Moor, R, Dresser, Gk, Gros, Ml, Schumann, Vc, Baur, M, Macdonald, C, Wirzba, B, Regalado, O, Srinathan, Sk, Ong, Dd, Todd, A, Abbas, S, Beattie, Ws, Chan, Vw, Chin, Kj, Wijeysundera, Dn, Graham, Mm, Irwin, M, Jacka, M, El Beheiry, H, Mcmullen, Sm, Macdonald, P, Akhtar, Z, Ayad, S, Buttar, M, Deroee, A, Eshraghi, Y, Fergany, A, Finnigan, P, Fu, A, Grady, M, Helper, S, Hesler, B, Honar, H, Hutcherson, M, Krebs, V, Lee, J, Malik, M, Podolyak, A, Salmasi, V, Arora, H, Coombs, Rf, Martinelli, Sm, Bergese, Sd, Melibary, Sb, Uribe, Aa, Jordan, M, Miller, Sa, Cata, Jp, Nemergut, Ec, Candiotti, Ka, Memtsoudis, Sg, Mckay, Re, Montes, Fr, Parra, Ga, Rojas, Mf, Plata, R, Vásquez, Sm, Sarquis, T, Haider, Z, Jane, Nb, Lanjewar, Pp, Rahate, Pv, Mehra, Br, Premendaran, B, Abraham, V, George, P, Kumar, P, Gaikwad, Sb, Mohan, Nv, Sidhu, G, Alvarez, J, Gonzalez, R, Maestre, M, Popova, E, Urrutia, G, de Nadal, M, González Suárez, S, González Tallada, A, Plou, P, Mena, E, Riveira, C, del Valle, S, Tena, B, Lang, Sa, Ludbrook, Gl, Painter, Tw, Terblanche, Nc, Osborne, C, Mahood, Jr, Myles, Ps, Sivalingam, P, Riedel, B, Elhalawani, I, Drummond, L, Mugabi, A, Naidoo, P, Myburgh, Al, Porrill, Os, Diedericks, Bj, Turton, Ew, Bøgeskov, M, Dahl, Rm, Madsen, Mv, Søndergaard, Es, Bauer, Ne, Martinsen, Kr, Choi, Gy, Gin, T, Ng, Ss, Bidgoli, Sj, Van der Linden PJ, De Kock, M, Kabon, B, Luf, F, Radonic, M, Ishtiaq, O, Safdar, J, Acuna Villaorduna, A, Barrionuevo, P, Castaneda Guarderas, A, Caballero, Ja, Lau, Ve, Aphang Lam MR, Lembo, R, Gossetti, Bruno, Jara, X, Leon, P, Ong, G, Lee, Hs, Seeberger, Ee, Seeberger, Md, Alfonsi, P, Coriat, P, Piriou, V, Vizcaychipi, Mp, Rech, Rl, Bergo, Rr, Walker, S, Rodseth, R, Lemanach, Y, Díaz, R, Cortés, Ol, Wetterslev, J, Hoeft, A, Wittmann, M, Chan, M, Landoni, G, Conen, D, Balaji, P, Sovereign, T, Blake, L, Sephton, J, Serra, A, Agrippa, C, Lawrence, M, Biccard, B, Gluud, C, Baigent, C, Karthikeyan, G, Auerbach, A, Beattie, S, Buckley, N, Douketis, J, Gerstein, H, Ghali, W, Hart, R, Hill, M, Mcalister, F, Mcauley, D, Miller, S, O'Donnell, M, Pais, P, Parlow, J, Schricker, T, Sessler, D, Simunovic, M, Teoh, K, Walsh, M, Wijeysundera, D, Yang, H, Alshalash, S, Bessissow, A, Duceppe, E, Khalid, Z, Khan, J, Lauw, M, Martinsen, K, Neary, J, Oczkowski, W, Papina, M, Seeberger, M, Tandon, V, Thomas, S, Friedman, L, Cheng, D, Johnstone, D, Lowenstein, E, and Roberts, R.

Subjects
Male, hypotension, drug safety, Heart disease, Myocardial Infarction, Kaplan-Meier Estimate, high risk patient, noncardiac surgery, surgery, low drug dose, hazard ratio, Postoperative Complications, dose response, Adrenergic alpha-2 Receptor Agonists, Myocardial infarction, Treatment Failure, risk reduction, Aspirin, Hazard ratio, drug effect, article, risk assessment, General Medicine, Middle Aged, Clonidine, aged, female, priority journal, Anesthesia, factorial design, Surgical Procedures, Operative, Female, Hypotension, medicine.drug, medicine.medical_specialty, heart infarction, perioperative period, preoperative treatment, Placebo, bradycardia, Perioperative Care, length of stay, death, medicine, Humans, controlled study, human, Aged, treatment duration, business.industry, Perioperative, Vascular surgery, acetylsalicylic acid, medicine.disease, major clinical study, purl.org/pe-repo/ocde/ford#3.02.00 [https], drug efficacy, multicenter study, randomized controlled trial, incidence, treatment outcome, placebo, business, heart arrest
Abstract

Background: Marked activation of the sympathetic nervous system occurs during and after noncardiac surgery. Low-dose clonidine, which blunts central sympathetic outflow, may prevent perioperative myocardial infarction and death without inducing hemodynamic instability. Methods: We performed a blinded, randomized trial with a 2-by-2 factorial design to allow separate evaluation of low-dose clonidine versus placebo and low-dose aspirin versus placebo in patients with, or at risk for, atherosclerotic disease who were undergoing noncardiac surgery. A total of 10,010 patients at 135 centers in 23 countries were enrolled. For the comparison of clonidine with placebo, patients were randomly assigned to receive clonidine (0.2 mg per day) or placebo just before surgery, with the study drug continued until 72 hours after surgery. The primary outcome was a composite of death or nonfatal myocardial infarction at 30 days. Results: Clonidine, as compared with placebo, did not reduce the number of primary-outcome events (367 and 339, respectively; hazard ratio with clonidine, 1.08; 95% confidence interval [CI], 0.93 to 1.26; P=0.29). Myocardial infarction occurred in 329 patients (6.6%) assigned to clonidine and in 295 patients (5.9%) assigned to placebo (hazard ratio, 1.11; 95% CI, 0.95 to 1.30; P=0.18). Significantly more patients in the clonidine group than in the placebo group had clinically important hypotension (2385 patients [47.6%] vs. 1854 patients [37.1%]; hazard ratio 1.32; 95% CI, 1.24 to 1.40; P

Published
2014

4. Dapagliflozin for Critically Ill Patients With Acute Organ Dysfunction: The DEFENDER Randomized Clinical Trial.

Author

Tavares CAM, Azevedo LCP, Rea-Neto Á, Campos NS, Amendola CP, Kozesinski-Nakatani AC, David-João PG, Lobo SM, Filiponi TC, Almeida GMB, Bergo RR, Guimarães-Júnior MRR, Figueiredo RC, Castro JR, Schuler CJ, Westphal GA, Carioca ACR, Monfradini F, Nieri J, Neves FMO, Paulo JA, Albuquerque CSN, Silva MCR, Kosiborod MN, Pereira AJ, Damiani LP, Corrêa TD, Serpa-Neto A, Berwanger O, and Zampieri FG

Subjects
Aged, Female, Humans, Male, Middle Aged, Hospital Mortality, Intensive Care Units, Length of Stay, Renal Replacement Therapy, Brazil, Benzhydryl Compounds therapeutic use, Critical Illness therapy, Glucosides therapeutic use, Glucosides adverse effects, Multiple Organ Failure drug therapy, Multiple Organ Failure mortality, Sodium-Glucose Transporter 2 Inhibitors therapeutic use, Sodium-Glucose Transporter 2 Inhibitors adverse effects
Abstract

Importance: Sodium-glucose cotransporter 2 (SGLT-2) inhibitors improve outcomes in patients with type 2 diabetes, heart failure, and chronic kidney disease, but their effect on outcomes of critically ill patients with organ failure is unknown., Objective: To determine whether the addition of dapagliflozin, an SGLT-2 inhibitor, to standard intensive care unit (ICU) care improves outcomes in a critically ill population with acute organ dysfunction., Design, Setting, and Participants: Multicenter, randomized, open-label, clinical trial conducted at 22 ICUs in Brazil. Participants with unplanned ICU admission and presenting with at least 1 organ dysfunction (respiratory, cardiovascular, or kidney) were enrolled between November 22, 2022, and August 30, 2023, with follow-up through September 27, 2023., Intervention: Participants were randomized to 10 mg of dapagliflozin (intervention, n = 248) plus standard care or to standard care alone (control, n = 259) for up to 14 days or until ICU discharge, whichever occurred first., Main Outcomes and Measures: The primary outcome was a hierarchical composite of hospital mortality, initiation of kidney replacement therapy, and ICU length of stay through 28 days, analyzed using the win ratio method. Secondary outcomes included the individual components of the hierarchical outcome, duration of organ support-free days, ICU, and hospital stay, assessed using bayesian regression models., Results: Among 507 randomized participants (mean age, 63.9 [SD, 15] years; 46.9%, women), 39.6% had an ICU admission due to suspected infection. The median time from ICU admission to randomization was 1 day (IQR, 0-1). The win ratio for dapagliflozin for the primary outcome was 1.01 (95% CI, 0.90 to 1.13; P = .89). Among all secondary outcomes, the highest probability of benefit found was 0.90 for dapagliflozin regarding use of kidney replacement therapy among 27 patients (10.9%) in the dapagliflozin group vs 39 (15.1%) in the control group., Conclusion and Relevance: The addition of dapagliflozin to standard care for critically ill patients and acute organ dysfunction did not improve clinical outcomes; however, confidence intervals were wide and could not exclude relevant benefits or harms for dapagliflozin., Trial Registration: ClinicalTrials.gov Identifier: NCT05558098.

Published
2024
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5. Primary results of the brazilian registry of atherothrombotic disease (NEAT).

Author

de Barros E Silva PGM, do Nascimento CT, Pedrosa RP, Nakazone MA, do Nascimento MU, de Araújo Melo L, Júnior OLS, Zimmermann SL, de Melo RMV, Bergo RR, Precoma DB, Tramujas L, Lima EG, Dantas JMM, do Amaral Baruzzi AC, Flumignan RLG, de Oliveira Paiva MSM, Gowdak LHW, de Carvalho PN, de Figueiredo Neto JA, Silvestre OM, Fioranelli A, Vieira RD', Horak ACP, Miyada DHK, Kojima FCS, de Oliveira JS, de Oliveira Silva L, Pavanello R, Ramacciotti E, and Lopes RD

Subjects
Aged, Female, Humans, Male, Brazil epidemiology, Prospective Studies, Registries, Risk Factors, Rivaroxaban therapeutic use, Middle Aged, Multicenter Studies as Topic, Observational Studies as Topic, Coronary Artery Disease drug therapy, Peripheral Arterial Disease epidemiology
Abstract

There is limited contemporary prospective real-world evidence of patients with chronic arterial disease in Latin America. The Network to control atherothrombosis (NEAT) registry is a national prospective observational study of patients with known coronary (CAD) and/or peripheral arterial disease (PAD) in Brazil. A total of 2,005 patients were enrolled among 25 sites from September 2020 to March 2022. Patient characteristics, medications and laboratorial data were collected. Primary objective was to assess the proportion of patients who, at the initial visit, were in accordance with good medical practices (domains) for reducing cardiovascular risk in atherothrombotic disease. From the total of patients enrolled, 2 were excluded since they did not meet eligibility criteria. Among the 2,003 subjects included in the analysis, 55.6% had isolated CAD, 28.7% exclusive PAD and 15.7% had both diagnoses. Overall mean age was 66.3 (± 10.5) years and 65.7% were male patients. Regarding evidence-based therapies (EBTs), 4% were not using any antithrombotic drug and only 1.5% were using vascular dose of rivaroxaban (2.5 mg bid). Only 0.3% of the patients satisfied all the domains of secondary prevention, including prescription of EBTs and targets of body-mass index, blood pressure, LDL-cholesterol, and adherence of lifestyle recommendations. The main barrier for prescription of EBTs was medical judgement. Our findings highlight that the contemporary practice does not reflect a comprehensive approach for secondary prevention and had very low incorporation of new therapies in Brazil. Large-scale populational interventions addressing these gaps are warranted to improve the use of evidence-based therapies and reduce the burden of atherothrombotic disease.ClinicalTrials.gov NCT04677725., (© 2024. The Author(s).)

Published
2024
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6. Dapagliflozin in patients with critical illness: rationale and design of the DEFENDER study.

Author

Tavares CAM, Azevedo LCP, Rea-Neto Á, Campos NS, Amendola CP, Bergo RR, Kozesinski-Nakatani AC, David-João PG, Westphal GA, Guimarães Júnior MRR, Lobo SMA, Tavares MS, Dracoulakis MDA, Souza GM, Almeida GMB, Gebara OCE, Tomba PO, Albuquerque CSN, Silva MCR, Pereira AJ, Damiani LP, Corrêa TD, Serpa-Neto A, Berwanger O, and Zampieri FG

Subjects
Adult, Humans, Multiple Organ Failure drug therapy, Multicenter Studies as Topic, Critical Illness therapy, Sodium-Glucose Transporter 2 Inhibitors therapeutic use
Abstract

Background: Critical illness is a major ongoing health care burden worldwide and is associated with high mortality rates. Sodium-glucose cotransporter-2 inhibitors have consistently shown benefits in cardiovascular and renal outcomes. The effects of sodium-glucose cotransporter-2 inhibitors in acute illness have not been properly investigated., Methods: DEFENDER is an investigator-initiated, multicenter, randomized, open-label trial designed to evaluate the efficacy and safety of dapagliflozin in 500 adult participants with acute organ dysfunction who are hospitalized in the intensive care unit. Eligible participants will be randomized 1:1 to receive dapagliflozin 10mg plus standard of care for up to 14 days or standard of care alone. The primary outcome is a hierarchical composite of hospital mortality, initiation of kidney replacement therapy, and intensive care unit length of stay, up to 28 days. Safety will be strictly monitored throughout the study., Conclusion: DEFENDER is the first study designed to investigate the use of a sodium-glucose cotransporter-2 inhibitor in general intensive care unit patients with acute organ dysfunction. It will provide relevant information on the use of drugs of this promising class in critically ill patients., Clinicaltrials.gov Registry: NCT05558098.

Published
2023
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7. P2Y12 inhibitor monotherapy versus dual antiplatelet therapy in patients with acute coronary syndromes undergoing coronary stenting: rationale and design of the NEOMINDSET Trial.

Author

Guimarães PO, Franken M, Tavares CAM, Silveira FS, Antunes MO, Bergo RR, Joaquim RM, Hirai JCS, Andrade PB, Pitta FG, Mariani J Jr, Nascimento BR, de Paula JET, Silveira MS, Costa TAO, Dall'Orto FTC, Serpa RG, Sampaio FBA, Ohe LN, Mangione FM, Furtado RHM, Sarmento-Leite R, Monfardini F, Assis SRL, Nicolau JC, Sposito AC, Lopes RD, Onuma Y, Valgimigli M, Angiolillo DJ, Serruys PW, Berwanger O, Bacal F, and Lemos PA

Subjects
Humans, Platelet Aggregation Inhibitors therapeutic use, Ticagrelor therapeutic use, Prasugrel Hydrochloride therapeutic use, Drug Therapy, Combination, Aspirin therapeutic use, Hemorrhage chemically induced, Treatment Outcome, Acute Coronary Syndrome drug therapy, Acute Coronary Syndrome surgery, Percutaneous Coronary Intervention adverse effects, Drug-Eluting Stents
Abstract

Dual antiplatelet therapy (DAPT) is currently the standard of care after percutaneous coronary intervention (PCI). Recent studies suggest that reducing DAPT to 1-3 months followed by an aspirin-free single antiplatelet therapy (SAPT) strategy with a potent P2Y 12 inhibitor is safe and associated with less bleeding. However, to date, no randomised trial has tested the impact of initiating SAPT immediately after PCI, particularly in patients with acute coronary syndromes (ACS). NEOMINDSET is a multicentre, randomised, open-label trial with a blinded outcome assessment designed to compare SAPT versus DAPT in 3,400 ACS patients undergoing PCI with the latest-generation drug-eluting stents (DES). After successful PCI and up to 4 days following hospital admission, patients are randomised to receive SAPT with a potent P2Y 12 inhibitor (ticagrelor or prasugrel) or DAPT (aspirin plus a potent P2Y 12 inhibitor) for 12 months. Aspirin is discontinued immediately after randomisation in the SAPT group. The choice between ticagrelor and prasugrel is at the investigator's discretion. The primary hypothesis is that SAPT will be non-inferior to DAPT with respect to the composite endpoint of all-cause mortality, stroke, myocardial infarction or urgent target vessel revascularisation, but superior to DAPT on rates of bleeding defined by Bleeding Academic Research Consortium 2, 3 or 5 criteria. NEOMINDSET is the first study that is specifically designed to test SAPT versus DAPT immediately following PCI with DES in ACS patients. This trial will provide important insights on the efficacy and safety of withdrawing aspirin in the early phase of ACS. (ClinicalTrials.gov: NCT04360720).

Published
2023
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8. Acetylcysteine for the prevention of renal outcomes in patients with diabetes mellitus undergoing coronary and peripheral vascular angiography: a substudy of the acetylcysteine for contrast-induced nephropathy trial.

Author

Berwanger O, Cavalcanti AB, Sousa AM, Buehler A, Castello-Júnior HJ, Cantarelli MJ, Mangione JA, Bergo RR, São Thiago LE, Nunes PM, da Motta PA, Kodama A, Victor E, Carvalho VO, and Sousa JE

Subjects
Acute Kidney Injury etiology, Acute Kidney Injury mortality, Aged, Coronary Angiography adverse effects, Coronary Artery Disease mortality, Diabetic Angiopathies mortality, Female, Free Radical Scavengers administration & dosage, Glomerular Filtration Rate, Humans, Incidence, Male, Middle Aged, Peripheral Vascular Diseases mortality, Placebos, Risk Factors, Treatment Failure, Acetylcysteine administration & dosage, Acute Kidney Injury prevention & control, Contrast Media adverse effects, Coronary Artery Disease diagnostic imaging, Diabetic Angiopathies diagnostic imaging, Peripheral Vascular Diseases diagnostic imaging
Abstract

Background: Diabetes mellitus represents an independent risk factor for contrast-induced acute kidney injury. We report the results of a prespecified substudy of patients with diabetes mellitus included in the Acetylcysteine for Contrast-Induced Nephropathy Trial (ACT), the largest randomized study evaluating the effects of acetylcysteine for the prevention of contrast-induced acute kidney injury conducted to date., Methods and Results: From the 2308 patients included in the ACT, 1395 had diabetes mellitus and were considered for the present analysis. The study drugs (acetylcysteine 1200 mg or matching placebo) were administered orally twice daily for 2 doses before and 2 doses after the procedure. The allocation was concealed (central Web-based randomization). Participants, healthcare staff, data collectors, and outcome assessors were blinded. All analysis followed the intention-to-treat principle. The incidence of contrast-induced acute kidney injury (primary end point) was 13.8% in the acetylcysteine group and 14.7% in the control group (relative risk 0.93; 95% confidence interval, 0.69-1.26; P=0.64). A combined end point of death or need for dialysis at 30 days was also similar in both the groups (2.2% and 2.1%, respectively; hazard ratio, 1.07; 95% confidence interval, 0.52-2.19; P=0.86)., Conclusions: In this subanalysis, acetylcysteine did not reduce the risk of contrast-induced acute kidney injury or other clinically relevant outcomes in patients with diabetes mellitus undergoing coronary and peripheral vascular angiography., Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00736866.

Published
2013
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