The Acetylcysteine for Contrast-Induced Nephropathy Trial

NCT00736866 | Completed Phase 3

• 1 other identifier: IEP- HCor 001/08
• Study Type: interventional
• Target: 2,300
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Failure

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Contrast-induced nephropathy incidence

  between 48 and 96 hours after angiographic procedures

Secondary Outcomes (3)

• 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

Study Arms (2)

Acetylcysteine

EXPERIMENTAL

Drug: Acetylcysteine

Control

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Acetylcysteine 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.

Acetylcysteine

Placebo 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.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant women, breastfeeding or aged below 45 years-old and with no efficacious contraceptive methods.
• Patients in dialysis
• 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.

Sponsors & Collaborators

• Hospital do Coracao: lead
• Medley Pharmaceutical Industry SA: collaborator

Study Sites (1)

Hospital do Coração

São Paulo, São Paulo, 04004030, Brazil

Location

Related Publications (3)

• 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.

  PMID: 23572490 DERIVED

• 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.

  PMID: 21859972 DERIVED

• 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.

  PMID: 19497091 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Eduardo Sousa, PhD

  Hospital do Coracao

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 14, 2008
• First Posted: August 18, 2008
• Study Start: August 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: July 12, 2010

Record last verified: 2008-08

Locations

BR (1)