Coronary Artery Disease Clinical Trial
Official title:
Antioxidants for Preventing Contrast-Induced Acute Kidney Injury After Coronary Artery Catheterization
In a double-blinded randomized clinical trial, all patients undergoing coronary artery catheterization who will met our criteria, will be enrolled into three groups to receive either, vitamin e, n-acetylcysteine, or placebo. The aim of study will be to compare the superiority of vitamin e over n-acetylcysteine for the prevention of contrast-induced acute kidney injury (CIAKI).
Patients aged ≥18 years with chronic kidney disease who undergo coronary catheterization will
be enrolled into the study if they meet the inclusion criteria. Patients will be randomly
assigned into three groups in a 1:1:1 ratio (Computer-generated random number will be used to
assign a patient in either group): we will use simple randomization for assigning each
patient in a group. The participants, physicians and outcome assessors will be blinded
throughout the trial until the opening of the randomization cold.
All patients will be entered into three group and they will be given normal saline 0.9%,
vitamin E, NAC, and the placebos of both regimens. The vitamin E will be given as a soft gel
capsule and its placebo will have the same shape and taste. The NAC will be given as an
effervescent tablet with a glass of water for consumption and its placebo will also have the
same shape and taste. These drugs will be given in addition to the routine hydration therapy
which will be given to all patients.
Primary outcome will be the development of CIAKI. Secondary outcomes will be the development
of major adverse cardiovascular events and any events till evaluating the CIAKI within 48-72
hours after intervention.
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