NASPI: N-Acetylcysteine vs. Ascorbic Acid for Prevention of Contrast Induced Nephropathy in Renal Insufficiency Undergoing Coronary Catheterization
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
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|
- The mean peak increase of serum creatinine concentration during day1 and day2.
- 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;
|Study Start Date:||February 2005|
|Estimated Study Completion Date:||April 2006|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00356954
|Korea, Republic of|
|Seoul National University Hospital , Cardiovascular Center|
|Seoul, Korea, Republic of|
|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|