The Acetylcysteine for Contrast-Induced Nephropathy Trial

Conditions

Acute Kidney Failure

Keywords

acetylcysteine, contrast-induced nephropathy, angiography, angioplasty with or without Stent

Brief 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.

Berwanger O, Cavalcanti AB, Sousa AM, Buehler A, Castello-Júnior HJ, Cantarelli MJ, Mangione JA, Bergo RR, São Thiago LE, Nunes PM, da Motta PA, Kodama A, Victor E, Carvalho VO, Sousa JE, Acetylcysteine for Contrast-Induced Nephropathy Trial Investigators.

2013-04-0921 citations

10.1161/circinterventions.112.000149

Acetylcysteine for prevention of renal outcomes in patients undergoing coronary and peripheral vascular angiography: main results from the randomized Acetylcysteine for Contrast-induced nephropathy Trial (ACT).

ACT Investigators.

2011-08-22214 citations

10.1161/circulationaha.111.038943

Rationale, design, and baseline characteristics of the Acetylcystein for Contrast-Induced nephropaThy (ACT) Trial: a pragmatic randomized controlled trial to evaluate the efficacy of acetylcysteine for the prevention of contrast-induced nephropathy.

ACT Trial Investigators.

2009-06-0415 citations

10.1186/1745-6215-10-38

Interventions

DRUGAcetylcysteine

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.

DRUGPlacebo

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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.

Design outcomes

Primary

Measure	Time frame
Contrast-induced nephropathy incidence	between 48 and 96 hours after angiographic procedures

Secondary

Measure	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

Countries

Brazil

Outcome results

None listed