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NASPI: N-Acetylcysteine vs. Ascorbic Acid for Prevention of Contrast Induced Nephropathy in Renal Insufficiency Undergoing Coronary Catheterization

This study has been completed.
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00356954
First received: July 26, 2006
Last updated: November 24, 2006
Last verified: November 2006
History of Changes
  Purpose

The contrast induced nephropathy (CIN) has been known to be associated with significant clinical and economic consequences. Many studies were performed to find the pathophysiology and preventive measures for CIN. But the results were somewhat frustrating. Recently, it has been reported that the N-acetylcysteine and ascorbic acid might have preventive effects for CIN by their antioxidant effects.There have been no study to compare these two antioxidant.


Condition Intervention Phase
Kidney Failure
 Drug: N-acetylcystein
Drug: ascorbic acid
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: N-Acetylcysteine vs. Ascorbic Acid for Prevention of Contrast Induced Nephropathy in Renal Insufficiency Undergoing Coronary Catheterization: NASPI Study-A Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • The mean peak increase of serum creatinine concentration during day1 and day2.

Secondary Outcome Measures:
  • Incidence of contrast induced nephropathy, defined as either a relative increase in serum creatinine
  • from baseline of >=25% or an absolute increase of >=0.5mg/dL(44.2µmol/L) during days 1 and 2.
  • Proportion of patients exhibiting an increase in serum creatinine of >=0.5mg/dL(44.2µmol/L)
  • proportion with a >=1.0 mg/dL(88.4µmol/L) increase in serum creatinine;

Estimated Enrollment: 250
Study Start Date: February 2005
Estimated Study Completion Date: April 2006
Detailed Description:

N-acetylcysteine and ascorbic acid may prevent the CIN in the patients with underlying renal insufficiency who is undergoing the coronary angiography. The effect may derive from the antioxidant function of these two antioxidant. We studied to find which of the two antioxidants is more beneficial in prevention of CIN

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Stable Angina pectoris patients
  • Patients who required the coronary catheterization
  • Creatinine clearance rates =<60 mL/min using the Cockcroft-Gault formula
  • Age of 19 or over 19

Exclusion Criteria:

  • Pregnancy
  • Lactation
  • Having received contrast media within 7 days of study entry
  • Emergent coronary angiography
  • Acute renal failure
  • End-stage renal disease requiring dialysis
  • History of hypersensitivity reaction to contrast media
  • Cardiogenic shock
  • Pulmonary edema
  • Multiple myeloma
  • Mechanical ventilation
  • Parenteral use of diuretics
  • Recent use of N-acetylcysteine
  • Recent use of Ascorbic acid
  • Recent use of statin
  • Use of metformin or nonsteroidal anti-inflammatory drugs within 48 hours of the procedure.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00356954

Locations
Korea, Republic of
Seoul National University Hospital , Cardiovascular Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Sang-Ho Jo, M.D. Seoul National University Hospital, Department of Internal Medicine/ Cardiovascular Center, Hallym University Sacred Heart Hospital
Principal Investigator: Bon-Kwon Koo, M.D., Ph.D. Seoul National University Hospital, Department of Internal Medicine/ Cardiovascular Center
Study Director: Hyo-Soo Kim, M.D.,Ph.D. Seoul National University Hospital, Department of Internal Medicine/ Cardiovascular Center
Study Chair: Byung-Hee Oh, M.D., Ph.D. Seoul National University Hospital, Department of Internal Medicine/ Cardiovascular Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00356954     History of Changes
Other Study ID Numbers: H-0509-517-158-2
Study First Received: July 26, 2006
Last Updated: November 24, 2006
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Seoul National University Hospital:
Kidney failure
Contrast media
Antioxidant
Prevention

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

ClinicalTrials.gov processed this record on May 23, 2013