N-Acetylcysteine vs. Ascorbic Acid for Prevention of Contrast Induced Nephropathy in Renal Insufficiency Undergoing Coronary Catheterization: NASPI Study-A Randomized Controlled Trial
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Kidney Failure
- Sponsor
- Seoul National University Hospital
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- The mean peak increase of serum creatinine concentration during day1 and day2.
- Status
- Completed
- Last Updated
- 19 years ago
Overview
Brief Summary
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.
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
Investigators
Eligibility 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
Outcomes
Primary Outcomes
The mean peak increase of serum creatinine concentration during day1 and day2.
Secondary Outcomes
- 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;