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.
Costa E, Reis H, de Assis GM, Cardoso GL, Barbosa MM, de Aguiar Filho FA, Gama CA, Silva MG, Aguiar BM, Ferreira MG, Feitosa GS, Victor Filho E, Rocha EB, Paiva MS, Czochra ER, Oliveira LA, de Oliveira IR, Pinheiro F, Dourado GO, Luna Filho AL, Pacheco A, Nunes PM, de Sá Filho AP, Martins HC, Lopes MA, Barros MA, Mattos C, Neves MA, Medeiros CR, Mattos C, Duarte L, Mattos C, Cramer H, Santos B Jr, Tura BR, Rodrigues CV, Terreiro LA, Alves MA, Soares JS, da Cunha CC, da Silva AC, Barcelos AM, Teixeira MA, Pinto JS, Saad JA, Mandil A, Falcheto E, Arêas CA, Dall'Orto FT, Freitas IF, Botelho RV, Seabra MD, Rosa CA, Pereira AD, Reis SS, Pereira VJ, Cunha SM, Ramalho GM, dos Santos RR, Muniz AJ, Loures JB, Amorim T, Muniz AJ, Loures JB, Abraão AC, Padilha RM, Sousa JE, Sousa AG, Moreira AC, Sousa AG, Feres F, Centemero M, Costa R, Esteves V, Almeida BO, Janella BL, Almeida MC, Stella FP, Almeida JD, Kloth VR, Mangione JA, Mauro MF, Tallo F, Santos DJ, Castello H, Cantarelli MJ, Baradel S, Stella FP, das Candeias MO, Kloth VR, Maiello JR, Seixas EA, Teixerense PT, de Toledo JF, Gubolino LA, Prates GJ, Yokoyama H, de Almeida P, Pessoa CM, Machado NC, Garzon PG, Antonângelo AF, Galeazzi PB, Queirantes CS, Cavalini VH, Labrunie A, de Andrade PB, Tebet MA, Devito FS, Farias CE, Nicolela EL Jr, Passos HM, Rubio P, Gubolino LA, Teixerense PT, de Toledo JF, Nunes GL, Roehrig C, de Oliveira AT, Wainstein MV, Ribeiro JP, Teixeira C, Atallah TN, Gomes C, Morelli H, Costantini CR, Tarbine SG, Santos MF, Ortiz CC, de Souza AB, Pecoits-Filho R, Koppe G, Hoffman PD, Faria Neto JR, Wang R, Cury C, Stadler N, Nercolini DC, Zanuzzi C, Bueno RR, Guerios EE, Tarastchuk JC, Peixoto ML, Labrunie A, de Andrade PB, Tebet MA, Thiago LE, Giuliano LC, Aranha FG, Misiak M, Thiago LE, Giuliano LC, Antunes MH, da Conceição RS, Abreu SM, Preve JC, Guimarães JS, de Araújo Filho D, Araújo EC, de Sousa LN, Fonseca AG, da Motta PA, Osterne EC, Da Motta VP, Zimmermann AC.
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.
- PMID:
- 19497091
- [PubMed - indexed for MEDLINE]
- PMCID: PMC2706243
Free PMC ArticleFigure 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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