Status:
COMPLETED
The Acetylcysteine for Contrast-Induced Nephropathy Trial
Lead Sponsor:
Hospital do Coracao
Collaborating Sponsors:
Medley Pharmaceutical Industry SA
Conditions:
Acute Kidney Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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....
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2010
Estimated Enrollment :
2300 Patients enrolled
Trial Details
Trial ID
NCT00736866
Start Date
August 1 2008
End Date
July 1 2010
Last Update
July 12 2010
Active Locations (1)
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1
Hospital do Coração
São Paulo, São Paulo, Brazil, 04004030