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

Primary Purpose

Kidney Failure

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

N-acetylcystein

ascorbic acid

About this trial

This is an interventional prevention trial for Kidney Failure focused on measuring Kidney failure, Contrast media, Antioxidant, Prevention

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Seoul National University Hospital , Cardiovascular Center

Outcomes

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;

Full Information

NCT ID

NCT00356954

First Posted

July 26, 2006

Last Updated

November 24, 2006

Sponsor

Seoul National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00356954

Brief Title

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

2. Study Status

Record Verification Date

November 2006

Overall Recruitment Status

Completed

Study Start Date

February 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

April 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Seoul National University Hospital

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Kidney Failure

Keywords

Kidney failure, Contrast media, Antioxidant, Prevention

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

250 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

N-acetylcystein

Intervention Type

Drug

Intervention Name(s)

ascorbic acid

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Incidence of contrast induced nephropathy, defined as either a relative increase in serum creatinine

Title

from baseline of >=25% or an absolute increase of >=0.5mg/dL(44.2µmol/L) during days 1 and 2.

Title

Proportion of patients exhibiting an increase in serum creatinine of >=0.5mg/dL(44.2µmol/L)

Title

proportion with a >=1.0 mg/dL(88.4µmol/L) increase in serum creatinine;

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sang-Ho Jo, M.D.

Organizational Affiliation

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

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

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

Organizational Affiliation

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

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

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

Organizational Affiliation

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

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

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

Organizational Affiliation

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

Official's Role

Study Chair

Facility Information:

Facility Name

Seoul National University Hospital , Cardiovascular Center

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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