NCT00736866

The Acetylcysteine for Contrast-Induced Nephropathy Trial

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,300 (estimated)
• Sponsor: Hospital do Coracao · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
DRUG	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.

Timeline

• Start date: 2008-08-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2008-08-18
• Last updated: 2010-07-12

Locations

1 site across 1 country: Brazil