drugset / Trial / NCT00497328

COmbined N-acetylcysteine and Bicarbonate in PCI To Reduce Adverse Side Effect of contrasT

NCT00497328

Phase 2/3 Completed 477 enrolled National University Hospital, Singapore
RandomizedParallel-groupOpen-labelPrevention

Summary

This is a randomised controlled trial to investigate the efficacy of preventive regimen of hydration with high dose oral N-acetylcysteine and intravenous sodium bicarbonate pretreatment in patients with stable advanced renal insufficiency (CKD stage 3 and 4:GFR 15-60ml/min/1.73m2 calculated by Modification of Diet in Renal Disease Study equation (MDRD formula)) undergoing elective percutaneous coronary intervention (PCI).

Timeline

Start
2007-08
Primary completion
2013-06
Completion
2013-06

Drugs

EvaluationDrugModalityDoseRoute
Subject N-acetylcysteine Small molecule 1200 mg Oral
Subject sodium bicarbonate Diagnostic / imaging agent 154 meq Intravenous