Mechanisms for an effect of acetylcysteine on renal function after exposure to radio-graphic contrast material: study protocol

乙酰半胱氨酸对放射线造影剂暴露后肾功能的影响机制:研究方案

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作者:Euan A Sandilands, Sharon Cameron, Frances Paterson, Sam Donaldson, Lesley Briody, Jane Crowe, Julie Donnelly, Adrian Thompson, Neil R Johnston, Ivor Mackenzie, Neal Uren, Jane Goddard, David J Webb, Ian L Megson, Nicholas Bateman, Michael Eddleston

Background

Contrast-induced nephropathy is a common complication of contrast administration in patients with chronic kidney disease and diabetes. Its pathophysiology is not well understood; similarly the role of intravenous or oral acetylcysteine is unclear. Randomized controlled trials to date have been conducted without detailed knowledge of the effect of acetylcysteine on renal function. We are conducting a detailed mechanistic study of acetylcysteine on normal and impaired kidneys, both with and without contrast. This information would guide the choice of dose, route, and appropriate outcome measure for future clinical trials in patients with chronic kidney disease.

Discussion

Contrast-induced nephropathy represents a significant source of hospital morbidity and mortality. Over the last ten years, acetylcysteine has been administered prior to contrast to reduce the risk of contrast-induced nephropathy. Randomized controlled trials, however, have not reliably demonstrated renoprotection; a recent large randomized controlled trial assessing a dose of oral acetylcysteine selected without mechanistic insight did not reduce the incidence of contrast-induced nephropathy. Our study should reveal the mechanism of effect of acetylcysteine on renal function and identify an appropriate route for future dose response studies and in time randomized controlled trials.

Trial registration

Clinical Trials.gov: NCT00558142; EudraCT: 2006-003509-18.

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