Please use this identifier to cite or link to this item: http://repositorio.unifesp.br/handle/11600/35182
Title: Rationale, study design, and analysis plan of the Alveolar Recruitment for ARDS Trial (ART): Study protocol for a randomized controlled trial
Authors: Cavalcanti, Alexandre B.
Berwanger, Otavio
Suzumura, Erica A.
Amato, Marcelo B. P.
Tallo, Fernando S.
Rezende, Ederlon A. C.
Telles, Jose M. M.
Romano, Edson
Guimaraes, Helio P.
Regenga, Marisa M.
Takahashi, Luzia N.
Teixeira, Cassiano
Oliveira, Roselaine P.
Carvalho, Vitor O.
Diaz-Quijano, Fredi A.
Carvalho, Carlos R. R.
Kodama, Alessandra A.
Ribeiro, Gisele F. M.
Abreu, Matheus O.
Oliveira, Ivonaldo M.
Guyatt, Gordon
Ferguson, Niall
Walter, Stephen
Vasconcelos, Marcia O. M.
Segundo, Valerio J.
Ferraz, Iris L.
Silva, Rosicley S.
Oliveira Filho, Wilson de
Silva, Nelson B.
Heirel, Debora C. B.
Takatani, Rodrigo R.
Sousa Neto, Jefferson A.
Neto, Jeronimo C. B.
Almeida, Samara D.
Chamy, Gauco
Goncalves Neto, Graciliano J. L.
Dias, Alysson P.
Silva, Rozangela R.
Tavares, Roberta C.
Souza, Marcia L. V. D.
Decio, Janaina C.
Lima, Cyntia M. L. S.
Ferreira Neto, Fleury
Oliveira, Katia R.
Dias, Polyana P. L. C.
Brandao, Andre L. S. B.
Ramos, Joroastro E.
Vasconcelos, Paula T.
Flores, Dimitri G.
Pinheiro Filho, Gilvan R.
Andrade, Isaac G.
Martinez, Amadeu
Franca, Gustavo G. P.
Monteiro, Livia L.
Correia, Emmanuel I. S.
Ribeiro, Wagner
Pereira, Antonio J.
Andrade, Wandalvo
Leite, Petronio A.
Filgueira Feto, Jose E.
Holanda, Marcelo A.
Amorim, Fabio F.
Margalho, Silviano B.
Domingues, Sergio M.
Ferreira, Claiton S.
Ferreira, Cassia M.
Rabelo, Livia A.
Duarte, Juliana N.
Lima, Fernando B.
Kawaguchi, Ines A. L.
Araujo Neto, Jose A.
Maia, Marcelo O.
Correa, Fabiano G.
Ribeiro, Rubens A. B.
Caser, Eliana
Moreira, Cora L. C. B.
Marcilino, Antonielen
Falcao, Jansen G.
Jesus, Karinne R.
Tcherniakovisk, Leo
Dutra, Victor G.
Thompson, Marlus M.
Piras, Claudio
Giuberti, Jonas
Silva, Albano S.
Santos, Jose R. P.
Potratz, Jorge L.
Paula, Ludmila N.
Bozi, Giovana G.
Gomes, Bruno C.
Vassallo, Paula F.
Rocha, Edson P.
Lima, Maria H. B. S.
Ferreira, Denise M.
Goncalves, Fernanda A. F.
Pereira, Sheila A.
Nobrega, Marciano S.
Caixeta, Carlos R.
Moraes, Ana P. P.
Carvalho, Alexandre G. R.
Alves, Janine D.
Carvalho, Frederico B.
Moreira, Fabiana B. R.
Starling, Claudia M.
Couto, Wivian A. D.
Bitencourt, Wesley S.
Peixoto, Daniela C.
Carvalho, Ivana L. V.
Silva, Silvangela G. A.
Felizardo, Livia R. S. M.
Magalhaes Nascimento, Francine J.
Santos, Priscila J. C. D.
Zanta, Camila C.
Martins, Marcele F.
Naves, Sergio A.
Silva, Fabiano D.
Laube, Gilberto
Galvao, Endi L.
Sousa, Marcelo F.
Souza, Marcia M. F.
Carvalho, Fernanda L. G.
Bergo, Ricardo R.
Rezende, Claudnei M.
Tamazato, Edys Y.
Sarat, Saturnino Campo
Almeida, Patricia S.
Gorski, Anthony G.
Matsui, Mirna
Eberhart Neto, Ervin
Nomoto, Silmara H.
Lima, Zildamara B.
Inagaki, Alexandre S.
Gil, Fernando S. U.
Araujo, Mario F. A.
Oliveira, Aline E.
Correa, Tiago A.
Mendonca, Angela
Reis, Helder
Carneiro, Saul R.
Castanelo, Carlos
Coelho, Edward
Amaral, Karine A. E. H.
Rego, Leila R. M.
Cunha, Adenard F. C.
Barra, Williams F.
Carneiro, Mauricio
Batista, Roseane A.
Zoghbi, Karina K.
Machado, Nelma J. N.
Ferreira, Reinaldo
Apoena, Pablo
Leao, Rosangela M.
Martins, Eliauria R.
Oliveira, Marcelo E.
Odir, Isaura
Kleber, Wladimy
Tavares, Daniele
Araujo, Marcelo E. U.
Brilhante, Yuzeth Nobrega
Tavares, Daniele C. C.
Kleber, Wladmy
Carvalho, Waneska L. N.
Winveler, Georgia F. P.
Chagas Filho, Aldir
Cavalcanti, Raphael Ali
Grion, Cintia M. C.
Reis, Andrezza T. J. B.
Festti, Josiane
Gimenez, Francielli M. P.
Larangeira, Alexandre S.
Cardoso, Lucienne T. Q.
Mezzaroba, Ana L.
Giancursi, Thiago S.
Kauss, Ivanil A. M.
Duarte, Pericles A. D.
Tozo, Tatiane C.
Peliser, Priscila
Germano, Almir
Gurgel, Sanderland J. T.
Silva, Sandra R. B.
Kuroda, Cristina M.
Herek, Andrea
Yamada, Sergio S.
Schiavetto, Paulo M.
Wysocki, Natacha
Matsubara, Rosely R.
Sales, Joao A. L.
Laprovita, Maria P.
Pena, Felipe M.
Sa, Alexandre
Vianna, Arthur
Verdeal, Juan C.
Martins, Gloria A.
Salgado, Diamantino R.
Coelho, Adalberto M.
Coelho, Milena P. P. M.
Morong, Aline S.
Poquiriqui, Rodolfo M. B.
Ferreira, Ana P.
Lucena, Debora N. L.
Marino, Nathalia F.
Moreira, Monique A.
Uratani, Cristiana C. S.
Severino, Marta A.
Silva, Patricia N.
Medeiros, Luciana G.
Chaves Filho, Francisco G.
Guimaraes, Daniela M. Q. S.
Rezende, Valeria M. C.
Carbonell, Roberto C. C.
Trindade, Renata S.
Pellegrini, Jose A. S.
Boniatti, Marcio M.
Santos, Moreno C.
Boldo, Rodrigo
Oliveira, Vanessa M.
Correa, Viviane M.
Nedel, Wagner
Schaich, Felipe
Tagliari, Luciana
Savi, Augusto
Schulz, Luis F.
Maccari, Juara G.
Seeger, Gabriela M.
Foernges, Rafael B.
Rieder, Marcelo M.
Becker, Daniel A.
Broilo, Fabiano P.
Schwarz, Patricia
Alencastro, Andre
Berto, Paula
Backes, Fabiane
Dias, Fernando S.
Blattner, Clarissa
Martins, Edna T. J.
Scaglia, Nris C.
Vieira, Silvia R. R.
Prado, Karen F.
Fialkow, Lea
Franke, Cristiano
Vieira, Debora F. V. B.
Moraes, Rafael B.
Marques, Leonardo S.
Hopf, Joao L. S.
Wawrzeniak, Iuri C.
Rech, Tatiana H.
Albuquerque, Regis B.
Guerreiro, Marcio O.
Teixeira, Luciano O.
Macedo, Pedro L.
Bainy, Marina P.
Ferreira, Edgard V.
Martins, Marcio A.
Andrade, Luciana A. S.
Machado, Fernando O.
Burigo, Ana C.
Pincelli, Mariangela
Kretzer, Lara
Maia, Israel S.
Cordeiro, Rodrigo B.
Westphal, Glauco
Caldeira, Milton
Cramer, Amanda S.
Dadam, Michelli M.
Barbosa, Pierry O.
Brilenger, Caroline O.
Horner, Marina B. W.
Oliveira, Glauce L.
Germiniani, Bruno C.
Teixeira, Cristina
Duarte, Robson
Assef, Maria G. P. L.
Rosso, Deorgelis
Bigolin, Rodrigo
Vanzuita, Raquel
Prado, Luiz F. A.
Oliveira, Andre L. V.
Reis, Diego L.
Morais, Mirene O.
Bastos, Rafael S.
Santana, Hericalizandra S. R.
Silva, Alline O.
Cacau, Lucas A. P.
Almeida, Marilia S.
Canavessi, Hugo Schlebinger
Nogueira, Eduardo E. F.
Pavia, Caio L. P.
Araujo, Jose F.
Lira, Jose A.
Nienstedt, Esteban C.
Smith, Thiago C.
Romano, Marcelo
Barros, Dalton
Costa, Andre F.
Takahashi, Luzia
Werneck, Vinicius
Farran, Jorge
Henriques, Lilian A.
Miura, Claudia
Lopes, Renato D. [UNIFESP]
Vendrame, Leticia S. [UNIFESP]
Guimaraes, Helio P. [UNIFESP]
Sandri, Priscila [UNIFESP]
Galassi, Marcela S. [UNIFESP]
Toufen, Carlos
Santiago, Roberta R. S.
Hirota, Adriana S.
Park, Marcelo
Azevedo, Luciano C. P.
Malbouison, Luiz M.
Costa, Maristela C.
Taniguchi, Leandro
Pompilio, Carlos E.
Baruzzi, Claudio
Andrade, Ana H. V.
Taira, Elisabete E.
Taino, Bruno
Oliveira, Clezio S.
Silva, Anselmo C.
Isola, Alexandre
Rezende, Ederlon
Rodrigues, Ricardo G.
Rangel, Vivian P. L.
Luzzi, Sergio
Giacomassi, Ivens W. S.
Nassar, Antonio P.
Souza, Ana R.
Rahal, Luciana
Nunes, Andre L.
Giannini, Fabio
Menescal, Brena
Morais, Jussara E. P.
Toledo, Diogo
Morsch, Rafaela D.
Merluzzi, Thalita
Amorim, Denise S.
Bastos, Ana C. A. G.
Santos, Patricia L.
Silva, Sabrina F.
Gallego, Raquel C. N.
Santos, Gheisa D.
Tucci, Mauro
Costa, Ramon T.
Santos, Lucio S.
Demarzo, Sergio E.
Schettino, Guilherme P. P.
Suzuki, Vivian C.
Patrocinio, Ana C. L.
Martins, Mariana L.
Passos, Denise B. V. G.
Cappi, Sylas B.
Goncalves, Iran
Borges, Marcos C.
Lovato, Wilson
Tavares, Marcel V.
Morales, Daniela
Machado, Luis A. M. W.
Torres, Franciele C. C.
Gomes, Tania M.
Cerantola, Rodrigo B.
Góis, Aécio Flávio Teixeira de [UNIFESP]
Marraccini, Thiago [UNIFESP]
Margarida, Kathia [UNIFESP]
Cavalcante, Eulalia [UNIFESP]
Machado, Flavia R. [UNIFESP]
Mazza, Bruno F. [UNIFESP]
Rossetti Santana, Heloisa B. [UNIFESP]
Mendez, Vanessa M. F. [UNIFESP]
Xavier, Patricia A. [UNIFESP]
Rabelo, Melina V. [UNIFESP]
Schievano, Fabiana R. [UNIFESP]
Pinto, Walkyria A. M. [UNIFESP]
Francisco, Renata S. [UNIFESP]
Ferreira, Elaine M. [UNIFESP]
Silva, Dafne C. B. [UNIFESP]
Arduini, Rodrigo G. [UNIFESP]
Aldrighi, Jose R.
Amaro, Andreson F.
Conde, Katia A. P.
Pereira, Cesar A.
Tarkieltaub, Elcio
Oliver, Wilson R.
Guadalupe, Erika G. L.
Acerbi, Paulo S. C.
Tomizuka, Carlos I.
Oliveira, Tatiana A.
Geha, Nadia N.
Mecatti, Giovana C.
Piovesan, Maysa Z. R.
Salomao, Maria C.
Moreno, Marcelo S.
Orsatti, Vinicius N.
Miranda, Whiniton
Ray, Alexandre
Guerra, Andre
Baptista Filho, Mario L. A.
Ferreira, Firmino H.
Viera Filho, Edesio
Canzi, Regina A.
Giuberti, Adriana F. T.
Garcez, Melissa C. M.
Pedro, A.
Sala, Andrea D.
Suguitani, Edmundo O.
Kazue, Priscila
Oliveira, Luiz R. C.
Infantini, Rodrigo M.
Carvalho, Fabricio R. T.
Andrade, Lucia C.
Santos, Thiago M.
Carmona, Cesar V.
Figueiredo, Luciana C.
Falcao, Antonio
Dragosavak, Desanka
Nogueira Filho, Wilson
Lunardi, Maria C.
Lago, Roberto
Gatti, Ciro
Chiasso, Tatiana M.
Santos, Grazielle O.
Silva, Aline C. F.
Araujo, Arthur C.
Ornellas, Izadora B.
Vieira, Vitor M.
Hajjar, Ludhmila A.
Figueiredo, Adelaide C.
Damasceno, Bruna
Pizarro, Camilo
Hinestrosa, Alfredo
Garcia L., Sandra M. C.
Gonzalez C., Octavio
Diaz S., Edgard
Raineri, Santi M.
Cortegiani, Andrea
ART Investigators
Writing Steering Comm
Trial Management Team
Data Monitoring Comm
Trial Ctr
Hosp Urgencias & Emergencias Rio Branco HUERB
Hosp & Pronto Socorro 28 Agosto
UNIMED Manaus
Fundacao Hosp Adriano Jorge
Hosp Santa Izabel Santa Casa Misericordia Bahia
Hosp Reg Juazeiro Gestao IMIP
Hosp Univ Prof Edgar Santos
Hosp Espanhol
Hosp Geral Roberto Santos
Hosp Messejana
Hosp Reg Samambaia
Hosp Reg Asa Norte HRAN
Hosp Santa Luzia
Hosp Santa Lucia
Hosp Anchieta
Ctr Integrado Atencao Saude CIAS
Hosp Evangel Cachoeiro Itapemirin
Vitoria Apart Hosp
Vila Velha Hosp
Hosp Clin UFES
Hosp Clin UFG
Hosp Geral Tarquinio Lopes Filho
UDI Hosp
Santa Casa Misericordia Ouro Preto
Hosp Eduardo de Menezes
Fundacao Hosp Sao Sebastiao
Hosp Conego Monte Raso
Hosp Municipal Odilon Behrens
Hosp Sao Lucas Governador Valadares
Santa Casa Caridade Diamantina
Hosp Coracao Pocos de Caldas
Hosp Reg Mato Grosso Sul Rosa Pedrossian
Fundacao Univ Fed Grande Dourados
Hosp Clin Gaspar Vianna
Hosp Saude Mulher
Fundacao Santa Casa Misericordia Para
Hosp Emergencia Trauma Senador Humberto Lucena
Hosp UNIMED Joao Pessoa
Hosp Alfa
Hosp Evangel Londrina
Hosp Univ Reg Norte Parana
Hosp Sao Lucas FAG
Hosp Univ Reg Maringa
Hosp Santa Casa Campo Mourao
Hosp Santa Tereza Guarapuava
Hosp Clin Padre Miguel
Hosp Prontocardio
Clin Sao Vicente
Hosp Barra DOr
Universidade Estadual de Maringá (UEM)
Hosp Estadual & Pronto Socorro Joao Paulo II
Hosp Geral Roraima
Hosp Nossa Senhora Conceicao
Hosp Moinhos Vento
UTI Cent Irmandade Santa Casa Misericordia Porto
UTI Pavilhao Pereira Filho Santa Casa Misericord
Hosp Sao Lucas PUCRS
Hosp Clin Porto Alegre HCPA
Hosp Univ Sao Francisco Paula
Hosp Coracao
Universidade Federal de Santa Catarina (UFSC)
Hosp Nereu Ramos
Hosp UNIMED Joinville
Hosp Sao Jose
Hosp Reg Hans Dieter Schmidt
Assoc Hosp & Maternidade Consul Carlos Renaux
Hosp Primavera
Hosp Urgencia Sergipe HUSE
Hosp Coracao HCor
Universidade Federal de São Paulo (UNIFESP)
Universidade de São Paulo (USP)
Hosp Moyses Deutsch MBoi Mirim
Hosp Servidor Publ Estadual
Hosp & Maternidade Sao Camilo
Hosp Sao Luiz
AC Camargo
Hosp Sirio Libanes
Hosp Luz
Hosp SaoLuiz
Hosp & Maternidade Sao Cristovao
Hosp Jose Soares Hungria
Hosp Municipal Prof Doutor Alipio Correa Neto
Hosp Univ Sao Francisco
Hosp UNIMED
Hosp Bandeirantes
Hosp Geral Sao Mateus Dr Manoel Bifulco
Inst Infectol Emilio Ribas
Universidade Estadual de Campinas (UNICAMP)
Hosp Clin Luzia de Pinho & Melo SPDM
Inst Canc Estado São Paulo ICESP
Hosp Maternidade UNIMED Leste Paulista
Fdn Cardiovasc Colombia
Los Comuneros Hosp Univ Bucaramanga
Org Latinoamer Fomento Invest Salud OLFSI
Medica Sur
Azienda Osped Univ P Giaccone
Hosp Coracao IEP HCor
Keywords: Acute respiratory distress syndrome
Alveolar recruitment
PEEP
Mechanical ventilation
Clinical trials
Randomized
Issue Date: 28-Aug-2012
Publisher: Biomed Central Ltd
Citation: Trials. London: Biomed Central Ltd, v. 13, 14 p., 2012.
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 cmH(2)O 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.
URI: http://repositorio.unifesp.br/handle/11600/35182
ISSN: 1745-6215
Other Identifiers: http://dx.doi.org/10.1186/1745-6215-13-153
Appears in Collections:Em verificação - Geral

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