Clinical trial NCT00356954: NASPI: N-Acetylcysteine vs. Ascorbic Acid for Prevention of Contrast Induced Nephropathy in Renal Insufficiency Undergoing Coronary Catheterization
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Failure
Keywords: Kidney failure
Contrast media
Antioxidant
Prevention
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2006-07-27
Enrollment: 250
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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
* 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.

Primary outcomes:
measure: The mean peak increase of serum creatinine concentration during day1 and day2.
Secondary outcomes:
measure: Incidence of contrast induced nephropathy, defined as either a relative increase in serum creatinine
measure: from baseline of >=25% or an absolute increase of >=0.5mg/dL(44.2µmol/L) during days 1 and 2.
measure: Proportion of patients exhibiting an increase in serum creatinine of >=0.5mg/dL(44.2µmol/L)
measure: proportion with a >=1.0 mg/dL(88.4µmol/L) increase in serum creatinine;
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital , Cardiovascular Center
Study officials:
affiliation: Seoul National University Hospital, Department of Internal Medicine/ Cardiovascular Center, Hallym University Sacred Heart Hospital
name: Sang-Ho Jo, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University Hospital, Department of Internal Medicine/ Cardiovascular Center
name: Bon-Kwon Koo, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University Hospital, Department of Internal Medicine/ Cardiovascular Center
name: Hyo-Soo Kim, M.D.,Ph.D.
role: STUDY_DIRECTOR
affiliation: Seoul National University Hospital, Department of Internal Medicine/ Cardiovascular Center
name: Byung-Hee Oh, M.D., Ph.D.
role: STUDY_CHAIR
References: