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

NCT00356954 | Completed Phase 4

• 1 other identifier: H-0509-517-158-2
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Failure

Keywords

Kidney failure; Contrast media; Antioxidant; Prevention

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (4)

• 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;

Interventions

N-acetylcystein DRUG

ascorbic acid DRUG

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital , Cardiovascular Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Hyo-Soo Kim, M.D.,Ph.D.

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

  STUDY DIRECTOR

• Byung-Hee Oh, M.D., Ph.D.

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 26, 2006
• First Posted: July 27, 2006
• Study Start: February 1, 2005
• Study Completion: April 1, 2006
• Last Updated: November 27, 2006

Record last verified: 2006-11

Locations

KR (1)