The Acetylcysteine for Contrast-Induced Nephropathy Trial

• Status: Completed
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital do Coracao
• Collaborator: Medley Pharmaceutical Industry SA
• Treatments: Acetylcysteine; N-monoacetylcystine

Criteria

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.