The Acetylcysteine for Contrast-Induced Nephropathy Trial

Hospital do Coracao2,300 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

2,300

Conditions

Acute Kidney Failure

Interventions

AcetylcysteineDRUG

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.

PlaceboDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hospital do Coração

São Paulo, São Paulo, Brazil

Outcomes

Primary Outcomes

Contrast-induced nephropathy incidence

Time frame: between 48 and 96 hours after angiographic procedures

Secondary Outcomes

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

Data from ClinicalTrials.gov

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