The Acetylcysteine for Contrast-Induced Nephropathy Trial

Phase 3

Completed

• Conditions: Acute Kidney Failure
• Interventions: Drug: Placebo; Drug: Acetylcysteine

• Registration Number: NCT00736866
• Lead Sponsor: Hospital do Coracao

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2008-08
• Study Start: 2008-08
• Study First Submitted: 2008-08-14
• Study First Submitted QC: 2008-08-14
• Study First Posted: 2008-08-18
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Last Update Submitted: 2010-07-08
• Last Update Posted: 2010-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2300

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Placebo	-
Acetylcysteine	Acetylcysteine	-

Primary Outcome Measures

Name	Time	Method
Contrast-induced nephropathy incidence	between 48 and 96 hours after angiographic procedures

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hospital do Coração; 🇧🇷 Sao Paulo, Brazil