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Abstract

N-acetyl cystein, ascorbic acid and intravenous hydration in reducing risk of contrast induced nephropathy: AJMER CIN study (Acetylcystein ascorbic acid to rejuvenate Medulla at high Risk for CIN): interim analysis

Background: Combination of two highly antioxidant drug, N-acetylcysteine and ascorbic acid along with hydration may help renal medulla to sustain oxidative stress (due to contrast agent) better when compared to intravenous hydration only.

Methods: It represents an interim analysis of ongoing ethically approved randomized study, with a plan to enroll 500 patients undergoing coronary catheterization who are at risk of developing contrast induced nephropathy. Patients received either combination of N-acetylcysteine, ascorbic acid and intravenous hydration (group A) or only hydration (group B).

Results: At first look analysis Z value (0.47) for interim analysis fell within the Haybittle-Peto boundary of +2.58 and -2.58 on either side favoring continuation of study.

Conclusion: Interim analysis favors continuation of ongoing study so as to provide statement after analysis of adequate sample size.


Author(s):

Kamal Kishor



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