The Acetylcysteine for Contrast-Induced Nephropathy Trial (ACT)
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|ClinicalTrials.gov Identifier: NCT00736866|
Recruitment Status : Completed
First Posted : August 18, 2008
Last Update Posted : July 12, 2010
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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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Kidney Failure||Drug: Acetylcysteine Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Pragmatic Randomized Clinical Trial Evaluating the Effect of Acetylcysteine for Contrast-induced Nephropathy|
|Study Start Date :||August 2008|
|Actual Primary Completion Date :||July 2010|
|Actual Study Completion Date :||July 2010|
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.
- 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 ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
At least one of the following criteria:
- Aged more than 70 years-old
- Chronic renal failure (defined as serum creatinine higher than 1.5mg/dL within the last 3 months)
- Diabetes mellitus
- Congestive heart failure or ventricular disfunction (left ventricular ejection fraction less than 0.45)
- Shock or intra-aortic balloon pump use
- Urgency or emergency procedures
- Pregnant women, breastfeeding or aged below 45 years-old and with no efficacious contraceptive methods.
- Patients in dialysis
- Previous inclusion in this trial
- Patient refusal to informed consent
- Pacientes com Infarto Agudo do Miocárdio com supradesnivelamento do segmento S-T nos quais não seja possível administrar o protocolo de hidratação pré e pós-procedimento.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00736866
|Hospital do Coração|
|Sao Paulo, Brazil, 04004030|
|Principal Investigator:||Eduardo Sousa, PhD||Hospital do Coracao|
|Responsible Party:||Otavio Berwanger, Hospital do Coracao|
|Other Study ID Numbers:||
IEP- HCor 001/08
|First Posted:||August 18, 2008 Key Record Dates|
|Last Update Posted:||July 12, 2010|
|Last Verified:||August 2008|
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