COmbined N-acetylcysteine and Bicarbonate in PCI To Reduce Adverse Side Effect of contrasT (CONTRAST)
Contrast Induced Nephropathy
About this trial
This is an interventional prevention trial for Contrast Induced Nephropathy focused on measuring contrast induced nephropathy
Eligibility 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
Sites / Locations
- The Heart Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Other
Other
Other
N-acetylcysteine Group (NAC)
Sodium Bicarbonate Group (SOB)
Combination Group (COM: NAC and SOB)
N-acetylcysteine Group (NAC) Intravenous infusion 154mEq/L of sodium chloride (0.9% normal saline) at a rate of 1mL/kg/hour from 12 hours before till 6 hours after cardiac catheterization Oral NAC 1200mg dissolve in 250ml of water twice a day the day before to the day after the procedure (total 6 doses)
Sodium Bicarbonate Group (SOB) Intravenous infusion154meq/L sodium bicarbonate in 5% dextrose in water at a rate of 3 mL/kg/hour for 1 hour immediately before radiocontrast injection. For patients weighing more than 110 kg, the initial fluid bolus and drip will be limited to those doses administered to a patient weighing 110 kg. Intravenous infusion154meq/L sodium bicarbonate in 5% dextrose in water at a rate of 1 mL/kg/hour during the contrast exposure and for 6 hours after the procedure
Combination Group (COM: NAC and SOB) Intravenous infusion of 154 meq/l sodium bicarbonate at a rate of 3ml/kg/hour for 1 hour before cardiac catheterization and 1 ml/kg/hour till 6 hours after procedure Oral NAC 1200mg dissolve in 250ml of water twice a day the day before to the day after the procedure (total 6 doses). All patients will be monitored regularly for pulmonary congestion and hemodynamics compromise hourly after PCI for 6 hours and every 4 hour thereafter for 24 hours.