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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT00497328
First received: July 4, 2007
Last updated: January 13, 2014
Last verified: January 2014
  Purpose

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
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00497328

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

No publications provided

Responsible Party: National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT00497328     History of Changes
Other Study ID Numbers: SQCIN01
Study First Received: July 4, 2007
Last Updated: January 13, 2014
Health Authority: Singapore: Singapore Clinical Research Institute

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

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases
Acetylcysteine
N-monoacetylcystine
Anti-Infective Agents
Antidotes
Antioxidants
Antiviral Agents
Expectorants
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014