The Acetylcysteine for Contrast-Induced Nephropathy Trial (ACT)
The purpose of this study is to evaluate the efficacy of acetylcysteine compared to placebo for the contrast-induced nephropathy prevention, between 48 and 96 hours after procedures that use contrast.
Contrast-induced nephropathy is defined as an increase of 25% in serum creatinine before the procedure.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||A Pragmatic Randomized Clinical Trial Evaluating the Effect of Acetylcysteine for Contrast-induced Nephropathy|
- Contrast-induced nephropathy incidence [ Time Frame: between 48 and 96 hours after angiographic procedures ]
- Combined outcome of total mortality, dialysis indication or basal serum creatinine duplication [ Time Frame: within 30 days ]
- Combined outcome of total mortality or dialysis indication [ Time Frame: within 30 days ]
- The individual components of the combined outcome [ Time Frame: within 30 dias ]
|Study Start Date:||August 2008|
|Study Completion Date:||July 2010|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
Acetylcysteine: 1200 mg every 12 hours for a total of 4 doses. Treatment is to be started 12 hours before angiography, that is, two doses should be administered before it. When this is not achievable, at least one dose should be administered before angiography.
|Placebo Comparator: Control||
Placebo of Acetylcysteine: every 12 hours PO, for a total of 4 doses. Treatment is to be started 12 hours before angiography, that is, two doses should be administered before it. When this is not achievable, at least one dose should be administered before angiography.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00736866
|Hospital do Coração|
|Sao Paulo, Brazil, 04004030|
|Principal Investigator:||Eduardo Sousa, PhD||Hospital do Coracao|