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

Sponsored by:	Seoul National University Hospital
Information provided by:	Seoul National University Hospital
ClinicalTrials.gov Identifier:	NCT00356954

Purpose

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.

Condition	Intervention	Phase
Kidney Failure	Drug: N-acetylcystein Drug: ascorbic acid	Phase IV

MedlinePlus related topics: Antioxidants Kidney Failure

Drug Information available for: Acetylcysteine Ascorbic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:

The mean peak increase of serum creatinine concentration during day1 and day2.

Secondary Outcome Measures:

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;

Estimated Enrollment:	250
Study Start Date:	February 2005
Estimated Study Completion Date:	April 2006

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

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00356954

Locations

Korea, Republic of
Seoul National University Hospital , Cardiovascular Center
Seoul, Korea, Republic of

Sponsors and Collaborators

Seoul National University Hospital

Investigators

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

More Information

Study ID Numbers:	H-0509-517-158-2
Study First Received:	July 26, 2006
Last Updated:	November 24, 2006
ClinicalTrials.gov Identifier:	NCT00356954
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Seoul National University Hospital:

Kidney failure
Contrast media
Antioxidant
Prevention

Study placed in the following topic categories:

Renal Insufficiency
Urologic Diseases
Acetylcysteine
Kidney Diseases

N-monoacetylcystine
Ascorbic Acid
Kidney Failure

Additional relevant MeSH terms:

Respiratory System Agents
Anti-Infective Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Growth Substances
Physiological Effects of Drugs
Antiviral Agents
Protective Agents

Pharmacologic Actions
Expectorants
Therapeutic Uses
Vitamins
Free Radical Scavengers
Micronutrients
Antidotes

ClinicalTrials.gov processed this record on January 16, 2009