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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

July 26, 2006
November 24, 2006
February 2005
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The mean peak increase of serum creatinine concentration during day1 and day2.
Same as current
Complete list of historical versions of study NCT00356954 on ClinicalTrials.gov Archive Site
  • 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;
  • 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);
  • the proportion with a >=1.0 mg/dL(88.4µmol/L) increase in serum creatinine;
  • and the mean peak increase in serum creatinine.
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NASPI: N-Acetylcysteine vs. Ascorbic Acid for Prevention of Contrast Induced Nephropathy in Renal Insufficiency Undergoing Coronary Catheterization
N-Acetylcysteine vs. Ascorbic Acid for Prevention of Contrast Induced Nephropathy in Renal Insufficiency Undergoing Coronary Catheterization: NASPI Study-A Randomized Controlled Trial

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.

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

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Kidney Failure
  • Drug: N-acetylcystein
  • Drug: ascorbic acid
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
250
April 2006
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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.
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00356954
H-0509-517-158-2
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Seoul National University Hospital
Not Provided
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
Seoul National University Hospital
November 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP