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

This study has been completed.
Information provided by (Responsible Party):
National University Hospital, Singapore Identifier:
First received: July 4, 2007
Last updated: January 13, 2014
Last verified: January 2014
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).

Condition Intervention Phase
Contrast Induced Nephropathy
Drug: N-acetylcysteine
Drug: Sodium Bicarbonate
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: An Open Labelled Randomized Multi-center Study of COmbined N-acetylcysteine and Bicarbonate in PCI To Reduce Incidence of Contrast Induced Nephropathy

Resource links provided by NLM:

Further study details as provided by National University Hospital, Singapore:

Primary Outcome Measures:
  • Development of contrast induced nephropathy (defined as >25% rise in baseline creatinine 48 hours post coronary intervention) [ Time Frame: 48 hours ]

Secondary Outcome Measures:
  • • Maximum change in serum creatinine level • Difference in hospital stay between groups • Need for hemodialysis • mortality • Maximum change in GFR • Peak creatinine level [ Time Frame: 30 days ]

Enrollment: 477
Study Start Date: August 2007
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
N-acetylcysteine Group (NAC)

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)

Drug: N-acetylcysteine
Sodium Bicarbonate Group (SOB)

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

Drug: Sodium Bicarbonate
Combination Group (COM: NAC and SOB)

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.

Drug: N-acetylcysteine Drug: Sodium Bicarbonate

  Show Detailed Description


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00497328

The Heart Institute
Singapore, Singapore, 119074
Sponsors and Collaborators
National University Hospital, Singapore
Principal Investigator: Huay C Tan, FAMS FSCAI The Heart Institute, National University Hospital of Singapore
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: National University Hospital, Singapore Identifier: NCT00497328     History of Changes
Other Study ID Numbers: SQCIN01
Study First Received: July 4, 2007
Last Updated: January 13, 2014

Keywords provided by National University Hospital, Singapore:
contrast induced nephropathy

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases
Antiviral Agents
Anti-Infective Agents
Respiratory System Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes processed this record on May 22, 2017