A Phase 4 interventional study of Simvastatin in Kidney Failure, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2007-07-12.
Sponsored by Seoul National University Hospital · Phase 4, Interventional, and Prevention
The contrast induced kidney toxicity has been known to affect the mortality and morbidity in the patients undergoing coronary angiography. But the mechanism and therapeutic strategy for it is not well known. Nowadays, it is reported that the N-acetylcysteine may have preventive effects for contrast induced kidney toxicity with its antioxidant effects.The statins have been reported to have many other effects other than the lipid lowering effect-including antioxidant effect, so we hypothesized that the antioxidant effect of simvastatin may prevent the contrast induced kidney toxicity.
The simvastatin may prevent the contrast agent induced acute renal failure in the patients with underlying renal insufficiency who is undergoing the coronary angiography. The effect may derive from the antioxidant function of simvastatin.
1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.
This study's enrollment of 320 is above the median of 43 across 1,503 interventional studies indexed under Renal Insufficiency.
Browse Renal Insufficiency studies →Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The mean peak increase of serum creatinine concentration during day1 and day2.
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), the proportion with a >=1.0 mg/dL(88.4µmol/L) increase in serum creatinine, and the mean peak increase in serum creatinine.
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Seoul National University Hospital