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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00497328
Recruitment Status : Completed
First Posted : July 6, 2007
Last Update Posted : January 14, 2014
Information provided by (Responsible Party):
National University Hospital, Singapore

Brief 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).

Condition or disease Intervention/treatment Phase
Contrast Induced Nephropathy Drug: N-acetylcysteine Drug: Sodium Bicarbonate Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 477 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : August 2007
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
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

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

Secondary Outcome Measures :
  1. • 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00497328

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The Heart Institute
Singapore, Singapore, 119074
Sponsors and Collaborators
National University Hospital, Singapore
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Principal Investigator: Huay C Tan, FAMS FSCAI The Heart Institute, National University Hospital of Singapore
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: National University Hospital, Singapore Identifier: NCT00497328    
Other Study ID Numbers: SQCIN01
First Posted: July 6, 2007    Key Record Dates
Last Update Posted: January 14, 2014
Last Verified: January 2014
Keywords provided by National University Hospital, Singapore:
contrast induced nephropathy
Additional relevant MeSH terms:
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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