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

dc.contributor.authorACT Trial Investigators
dc.contributor.authorTura, Bernardo R
dc.contributor.authorCramer, Helena
dc.contributor.authorSantos Jr., Bráulio
dc.date.accessioned2023-12-22T13:40:57Z
dc.date.available2023-12-22T13:40:57Z
dc.date.issued2009
dc.description.abstractBackground: 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.
dc.identifier.citationACT Trial Investigators. 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. Trials. 2009 Jun 4;10:38. doi: 10.1186/1745-6215-10-38.
dc.identifier.otherDOI: 10.1186/1745-6215-10-38
dc.identifier.urihttps://dspace.inc.saude.gov.br/handle/123456789/387
dc.language.isoen
dc.publisherTrials
dc.subject.meshAcetylcysteine / therapeutic useen
dc.subject.meshContrast Media / adverse effectsen
dc.subject.meshFree Radical Scavengers / therapeutic useen
dc.subject.meshHumansen
dc.subject.meshKidney Diseases / chemically induceden
dc.subject.meshKidney Diseases / prevention & controlen
dc.subject.meshPlacebosen
dc.subject.meshResearch Designen
dc.titleRationale, 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
dc.typeArticle
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