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

NCT ID: NCT00356954

Last Updated: 2006-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2006-04-30

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

Conditions

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Kidney Failure

Keywords

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Kidney failure Contrast media Antioxidant Prevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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N-acetylcystein

Intervention Type DRUG

ascorbic acid

Intervention Type DRUG

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.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Sang-Ho Jo, M.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital, Department of Internal Medicine/ Cardiovascular Center, Hallym University Sacred Heart Hospital

Bon-Kwon Koo, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital, Department of Internal Medicine/ Cardiovascular Center

Hyo-Soo Kim, M.D.,Ph.D.

Role: STUDY_DIRECTOR

Seoul National University Hospital, Department of Internal Medicine/ Cardiovascular Center

Byung-Hee Oh, M.D., Ph.D.

Role: STUDY_CHAIR

Seoul National University Hospital, Department of Internal Medicine/ Cardiovascular Center

Locations

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Seoul National University Hospital , Cardiovascular Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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H-0509-517-158-2

Identifier Type: -

Identifier Source: org_study_id