The Acetylcysteine for Contrast-Induced Nephropathy Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2010-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute Kidney Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Acetylcysteine

Group Type EXPERIMENTAL

Acetylcysteine

Intervention Type DRUG

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.

Control

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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.

Interventions

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Acetylcysteine

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.

Intervention Type DRUG

Placebo

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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No