The Acetylcysteine for Contrast-Induced Nephropathy Trial

Study Overview
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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.

Official Title
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A Pragmatic Randomized Clinical Trial Evaluating the Effect of Acetylcysteine for Contrast-induced Nephropathy

Conditions
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Acute Kidney Failure

Intervention / Treatment
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* Drug: Acetylcysteine
* Drug: Placebo


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acetylcysteine<br> | Drug: Acetylcysteine<br>* 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.<br>|
| Placebo Comparator: Control<br> | Drug: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contrast-induced nephropathy incidence |  | between 48 and 96 hours after angiographic procedures | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined outcome of total mortality, dialysis indication or basal serum creatinine duplication |  | within 30 days | 
| Combined outcome of total mortality or dialysis indication |  | within 30 days | 
| The individual components of the combined outcome |  | within 30 dias | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acetylcysteine, contrast-induced nephropathy, angiography, angioplasty with or without Stent