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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00356954
Enrollment
250
Registered
2006-07-27
Start date
2005-02-28
Completion date
2006-04-30
Last updated
2006-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Failure

Keywords

Kidney failure, Contrast media, Antioxidant, Prevention

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

Interventions

DRUGascorbic acid

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

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

Secondary

MeasureTime frame
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;

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026