Clinical trial NCT00736866: The Acetylcysteine for Contrast-Induced Nephropathy Trial
Official title: A Pragmatic Randomized Clinical Trial Evaluating the Effect of Acetylcysteine for Contrast-induced Nephropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Kidney Failure
Keywords: acetylcysteine
contrast-induced nephropathy
angiography
angioplasty with or without Stent
Lead sponsor: Hospital do Coracao
Sponsor class: OTHER
Collaborators: name: Medley Pharmaceutical Industry SA
First posted: 2008-08-18
Enrollment: 2300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Contrast-induced nephropathy incidence
timeFrame: between 48 and 96 hours after angiographic procedures
Secondary outcomes:
measure: Combined outcome of total mortality, dialysis indication or basal serum creatinine duplication
timeFrame: within 30 days
measure: Combined outcome of total mortality or dialysis indication
timeFrame: within 30 days
measure: The individual components of the combined outcome
timeFrame: within 30 dias
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Hospital do Coração
Study officials:
affiliation: Hospital do Coracao
name: Eduardo Sousa, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Berwanger O, Cavalcanti AB, Sousa AM, Buehler A, Castello-Junior HJ, Cantarelli MJ, Mangione JA, Bergo RR, Sao Thiago LE, Nunes PM, da Motta PA, Kodama A, Victor E, Carvalho VO, Sousa JE; Acetylcysteine for Contrast-Induced Nephropathy Trial Investigators. Acetylcysteine for the prevention of renal outcomes in patients with diabetes mellitus undergoing coronary and peripheral vascular angiography: a substudy of the acetylcysteine for contrast-induced nephropathy trial. Circ Cardiovasc Interv. 2013 Apr;6(2):139-45. doi: 10.1161/CIRCINTERVENTIONS.112.000149. Epub 2013 Apr 9.
citation: ACT Investigators. 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). Circulation. 2011 Sep 13;124(11):1250-9. doi: 10.1161/CIRCULATIONAHA.111.038943. Epub 2011 Aug 22.
citation: ACT Trial Investigators. 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. Trials. 2009 Jun 4;10:38. doi: 10.1186/1745-6215-10-38.