The Acetylcysteine for Contrast-Induced Nephropathy Trial

Acute Kidney Failure Clinical Trial

— ACT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00736866
• Other study ID #: IEP- HCor 001/08
• Status: Completed
• Phase: Phase 3
• First received: August 14, 2008
• Last updated: July 8, 2010
• Start date: August 2008
• Est. completion date: July 2010

Study information

• Verified date: August 2008
• Source: Hospital do Coracao
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2300
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Kidney Failure
• Acute Kidney Injury
• Kidney Diseases
• Renal Insufficiency

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
Brazil	Hospital do Coração	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Hospital do Coracao	Medley Pharmaceutical Industry SA

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Contrast-induced nephropathy incidence		between 48 and 96 hours after angiographic procedures	No
Secondary	Combined outcome of total mortality, dialysis indication or basal serum creatinine duplication		within 30 days	Yes
Secondary	Combined outcome of total mortality or dialysis indication		within 30 days	Yes
Secondary	The individual components of the combined outcome		within 30 dias	Yes