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Completed

NCT Number: NCT00356954

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

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.

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Key information

Conditions

Kidney Failure Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National University Hospital , Cardiovascular Center

Seoul, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

N-acetylcystein

Drug

ascorbic acid

Drug

Primary outcomes

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

Secondary outcomes

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

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

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

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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2005
Study completion
2006
First posted
Jul 27, 2006
Registry last updated
Nov 27, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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