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

Study Overview
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Brief Summary
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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
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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

Official Title
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N-Acetylcysteine vs. Ascorbic Acid for Prevention of Contrast Induced Nephropathy in Renal Insufficiency Undergoing Coronary Catheterization: NASPI Study-A Randomized Controlled Trial

Conditions
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Kidney Failure

Intervention / Treatment
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* Drug: N-acetylcystein
* Drug: ascorbic acid


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: N-acetylcystein|nan|
|Drug: ascorbic acid|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean peak increase of serum creatinine concentration during day1 and day2. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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; |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kidney failure, Contrast media, Antioxidant, Prevention