The Acetylcysteine for Contrast-Induced Nephropathy Trial (ACT)

Hospital do Coracao

Status and phase: Completed; Phase 3

Conditions: Acute Kidney Failure

Treatments: Drug: Placebo; Drug: Acetylcysteine

Study type: Interventional

Funder types: Other

Identifiers

NCT00736866

IEP- HCor 001/08

Details and patient eligibility

About

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.

Enrollment: 2,300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2,300 participants in 2 patient groups, including a placebo group

Acetylcysteine

Experimental group

Treatment:

Drug: Acetylcysteine

Control

Placebo Comparator group

Treatment:

Drug: Placebo