Rationale, design, and baseline characteristics of the Acetylcystein for Contrast-Induced nephropaThy (ACT) Trial: a pragmatic randomized controlled trial to evaluate the efficacy of acetylcysteine for the prevention of contrast-induced nephropathy

ACT Trial Investigators, Eduardo Costa, Hélder Reis, Gabriela M C C de Assis, Gracilene L Cardoso, Márcio M Barbosa, Francisco A A de Aguiar Filho, Carlos A V Gama, Marcelo Góes A Silva, Bruno M Aguiar, Marcelo G Ferreira, Gilson S Feitosa, Edgard Victor Filho, Emmanuel B D Rocha, Maria S M O Paiva, Eliana R Czochra, Ludmila A R R Oliveira, Itamar R de Oliveira, Flávia Pinheiro, Gilvan O Dourado, Antônio L Luna Filho, Amilson Pacheco, Paulo M S Nunes, Alcino P de Sá Filho, Helman C Martins, Marcelo A C Lopes, Marco A V Barros, Cláudia Mattos, Miguel A Neves, Cesar Rocha Medeiros, Cláudia Mattos, Leonardo Duarte, Cláudia Mattos, Helena Cramer, Bráulio Santos Jr, Bernardo R Tura, Cyro V Rodrigues, Luis A O Terreiro, Mônica A Alves, Jamil S Soares, Cristiane C da Cunha, Antônio C B da Silva, Alexandre M Barcelos, Marco A Teixeira, Joselena S Pinto, Jamil A Saad, Ari Mandil, Eduardo Falcheto, Carlos Augusto F Arêas, Frederico T C Dall'Orto, Ivan F Freitas, Roberto V Botelho, Míriam D G Seabra, César A S Rosa, Antônio D S Pereira, Samir S A Reis, Vilmar J Pereira, Silvia M C Cunha, Gustavo M Ramalho, Renata R dos Santos, Antônio J Muniz, João B L Loures, Thaís Amorim, Antônio J Muniz, João B L Loures, Ana Cristina O Abraão, Rone M Padilha, José E Sousa, Amanda G M R Sousa, Adriana C Moreira, Amanda G M R Sousa, Fausto Feres, Marinella Centemero, Ribamar Costa, Vinícius Esteves, Breno O Almeida, Bruno L Janella, Mariana C Almeida, Francisco P Stella, José D Almeida, Vivian R Kloth, José Armando Mangione, Maria F Z Mauro, Fernando Tallo, Diogo José A Santos, Hélio Castello, Marcelo J C Cantarelli, Sandra Baradel, Francisco P Stella, Marcos O das Candeias, Vivian R Kloth, José R Maiello, Emerson A Seixas, Pablo T Teixerense, João F B de Toledo, Luiz A Gubolino, Guilherme J G Prates, Hugo Yokoyama, Plínio de Almeida, Caio M A Pessoa, Nilton C S Machado, Pedro G A Garzon, André F P Antonângelo, Paula B S Galeazzi, Clotildes S P Queirantes, Vitor H Cavalini, André Labrunie, Pedro B de Andrade, Marden A Tebet, Fernando S Devito, Carlos E Farias, Eduardo L Nicolela Jr, Humberto M Passos, Priscila Rubio, Luiz A Gubolino, Pablo T Teixerense, João F B de Toledo, Gilberto L Nunes, Cíntia Roehrig, Alessandra T de Oliveira, Marco V Wainstein, Jorge P Ribeiro, Cátia Teixeira, Taufik N Atallah, Carlos Gomes, Henrique Morelli, Costantino R Costantini, Sérgio G Tarbine, Marcelo F Santos, Costantino C Ortiz, Anici B de Souza, Roberto Pecoits-Filho, Gelson Koppe, Priscila D Hoffman, José R Faria Neto, Ricardo Wang, Cristiane Cury, Newton Stadler, Deborah C Nercolini, Claudia Zanuzzi, Ronaldo R Bueno, Enio E Guerios, José C E Tarastchuk, Mário L Peixoto, André Labrunie, Pedro B de Andrade, Marden A Tebet, Luiz E S Thiago, Luiz C Giuliano, Fernando G Aranha, Marcielle Misiak, Luiz E S Thiago, Luiz C Giuliano, Maria H Antunes, Rosana S da Conceição, Silvia M Abreu, Julio C Preve, José S P Guimarães, David de Araújo Filho, Edmur C Araújo, Luciano N L de Sousa, Alberto G T Fonseca, Paulo A M da Motta, Evandro C V Osterne, Vicente P Da Motta, Anna C G R Zimmermann, ACT Trial Investigators, Eduardo Costa, Hélder Reis, Gabriela M C C de Assis, Gracilene L Cardoso, Márcio M Barbosa, Francisco A A de Aguiar Filho, Carlos A V Gama, Marcelo Góes A Silva, Bruno M Aguiar, Marcelo G Ferreira, Gilson S Feitosa, Edgard Victor Filho, Emmanuel B D Rocha, Maria S M O Paiva, Eliana R Czochra, Ludmila A R R Oliveira, Itamar R de Oliveira, Flávia Pinheiro, Gilvan O Dourado, Antônio L Luna Filho, Amilson Pacheco, Paulo M S Nunes, Alcino P de Sá Filho, Helman C Martins, Marcelo A C Lopes, Marco A V Barros, Cláudia Mattos, Miguel A Neves, Cesar Rocha Medeiros, Cláudia Mattos, Leonardo Duarte, Cláudia Mattos, Helena Cramer, Bráulio Santos Jr, Bernardo R Tura, Cyro V Rodrigues, Luis A O Terreiro, Mônica A Alves, Jamil S Soares, Cristiane C da Cunha, Antônio C B da Silva, Alexandre M Barcelos, Marco A Teixeira, Joselena S Pinto, Jamil A Saad, Ari Mandil, Eduardo Falcheto, Carlos Augusto F Arêas, Frederico T C Dall'Orto, Ivan F Freitas, Roberto V Botelho, Míriam D G Seabra, César A S Rosa, Antônio D S Pereira, Samir S A Reis, Vilmar J Pereira, Silvia M C Cunha, Gustavo M Ramalho, Renata R dos Santos, Antônio J Muniz, João B L Loures, Thaís Amorim, Antônio J Muniz, João B L Loures, Ana Cristina O Abraão, Rone M Padilha, José E Sousa, Amanda G M R Sousa, Adriana C Moreira, Amanda G M R Sousa, Fausto Feres, Marinella Centemero, Ribamar Costa, Vinícius Esteves, Breno O Almeida, Bruno L Janella, Mariana C Almeida, Francisco P Stella, José D Almeida, Vivian R Kloth, José Armando Mangione, Maria F Z Mauro, Fernando Tallo, Diogo José A Santos, Hélio Castello, Marcelo J C Cantarelli, Sandra Baradel, Francisco P Stella, Marcos O das Candeias, Vivian R Kloth, José R Maiello, Emerson A Seixas, Pablo T Teixerense, João F B de Toledo, Luiz A Gubolino, Guilherme J G Prates, Hugo Yokoyama, Plínio de Almeida, Caio M A Pessoa, Nilton C S Machado, Pedro G A Garzon, André F P Antonângelo, Paula B S Galeazzi, Clotildes S P Queirantes, Vitor H Cavalini, André Labrunie, Pedro B de Andrade, Marden A Tebet, Fernando S Devito, Carlos E Farias, Eduardo L Nicolela Jr, Humberto M Passos, Priscila Rubio, Luiz A Gubolino, Pablo T Teixerense, João F B de Toledo, Gilberto L Nunes, Cíntia Roehrig, Alessandra T de Oliveira, Marco V Wainstein, Jorge P Ribeiro, Cátia Teixeira, Taufik N Atallah, Carlos Gomes, Henrique Morelli, Costantino R Costantini, Sérgio G Tarbine, Marcelo F Santos, Costantino C Ortiz, Anici B de Souza, Roberto Pecoits-Filho, Gelson Koppe, Priscila D Hoffman, José R Faria Neto, Ricardo Wang, Cristiane Cury, Newton Stadler, Deborah C Nercolini, Claudia Zanuzzi, Ronaldo R Bueno, Enio E Guerios, José C E Tarastchuk, Mário L Peixoto, André Labrunie, Pedro B de Andrade, Marden A Tebet, Luiz E S Thiago, Luiz C Giuliano, Fernando G Aranha, Marcielle Misiak, Luiz E S Thiago, Luiz C Giuliano, Maria H Antunes, Rosana S da Conceição, Silvia M Abreu, Julio C Preve, José S P Guimarães, David de Araújo Filho, Edmur C Araújo, Luciano N L de Sousa, Alberto G T Fonseca, Paulo A M da Motta, Evandro C V Osterne, Vicente P Da Motta, Anna C G R Zimmermann

Abstract

Background: Aceltylcysteine has been evaluated in several small trials as a means of reducing the risk of contrast-induced nephropathy (CIN), however systematic reviews of these studies do not provide conclusive answers. Therefore, a large randomized controlled trial (RCT) is needed to provide a reliable answer as to whether acetylcysteine is effective in decreasing the risk of CIN in high-risk patients undergoing angiographic procedures.

Methods: ACT is a RCT of acetylcysteine versus placebo in 2,300 patients at-risk for CIN undergoing an intravascular angiographic procedure. The randomization list will be concealed. Participants, health care staff, investigators and outcome assessors will be blinded to whether patients receive acetylcysteine or placebo. All analysis will follow the intention-to-treat principle. The study drugs (acetylcysteine 1200 mg or placebo) will be administered orally twice daily for two doses before and two doses after the procedure. The primary outcome is the occurrence of CIN, defined as a 25% elevation of serum creatinine above baseline between 48 and 96 hours after angiography.

Discussion: The first patient entered the trial on September, 2008. Up to April 7, 2009, 810 patients had been included in 35 centers. The mean age was 69 (Standard deviation: 10), 18% had a baseline serum creatinine >1.5 mg/dL, 57% were diabetics and 13% had a history of heart failure. The ongoing ACT Trial is the largest multicentre RCT that will determine whether acetylcysteine is effective in decreasing the risk of CIN in patients at risk undergoing angiography.

Trial registration: Clinicaltrials.gov NCT00736866.

Figures

Figure 1
Figure 1
Flowchart of study drug administration. Angiography may be done at any time between 6 hours after the first study drug dose to just before the 3rd study drug dose.

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