Title
The Acetylcysteine for Contrast-Induced Nephropathy Trial
A Pragmatic Randomized Clinical Trial Evaluating the Effect of Acetylcysteine for Contrast-induced Nephropathy
Phase
Phase 3Lead Sponsor
Hospital do CoracaoStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Acute Kidney FailureIntervention/Treatment
acetylcysteine ...Study Participants
2300The 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.
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 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.
Inclusion Criteria: 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 Exclusion Criteria: 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.
