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

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National University Hospital, Singapore
• Treatments: Acetylcysteine; N-monoacetylcystine

Criteria

Inclusion Criteria:

• Age > 21 year

• Glomerular Filtration Rate (GFR) 15-60ml/min calculated by MDRD formula

• Scheduled to undergo elective PCI

• Able to receive 12 hours of pre-hydration

• Written informed consent

Exclusion Criteria:

• GFR less than 15ml/min or patients diagnosed with end stage renal failure

• Increase in serum creatinine levels of > 0.5mg/dl or 44umol/l in the previous 24 hours

• Preexisting dialysis

• Pulmonary edema or moderate to severe congestive heart failure (New York Heart

• Association [NYHA] III-IV)

• Patient unable to withstand the fluid load and hemodynamics compromise

• Uncontrolled hypertension (untreated systolic blood pressure > 160 mmHg, or diastolic blood pressure > 100mmHg.)

• Emergency cardiac catheterization (i.e. patient presenting with ST segment elevation myocardial infarction undergoing primary angioplasty)

• Recent exposure to radiographic contrast (within two days of the study).

• Allergic to radio-contrast

• Administration of sodium bicarbonate solution or NAC within 48 hours before the PCI.

• Patient unable to give consent

• Clinically vulnerable condition requiring continuous fluid therapy e.g. severe sepsis

• Use of NSAID, aminoglycocide, cyclosporin, cysplatin within 48 hours prior to PCI and throughout the study duration