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

Kidney Failure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00356954
• Other study ID #: H-0509-517-158-2
• Status: Completed
• Phase: Phase 4
• First received: July 26, 2006
• Last updated: November 24, 2006
• Start date: February 2005
• Est. completion date: April 2006

Study information

• Verified date: November 2006
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Kidney Failure
• Renal Insufficiency

Intervention

Drug:
• N-acetylcystein

• ascorbic acid

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital , Cardiovascular Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The mean peak increase of serum creatinine concentration during day1 and day2.
Secondary	Incidence of contrast induced nephropathy, defined as either a relative increase in serum creatinine
Secondary	from baseline of >=25% or an absolute increase of >=0.5mg/dL(44.2µmol/L) during days 1 and 2.
Secondary	Proportion of patients exhibiting an increase in serum creatinine of >=0.5mg/dL(44.2µmol/L)
Secondary	proportion with a >=1.0 mg/dL(88.4µmol/L) increase in serum creatinine;