The Effect of Acetylcysteine and Ascorbic Acid on the Prevention of Radiographic-contrast-agent Induced Reduction in Renal Function in ICU Patients.
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 100
- 主要终点
- Morbidity in the Intensive Care Unit
研究概览
简要总结
The use of N-acetylcysteine and ascorbic acid reduce the incidence of radiographic contrast agent induced reduction in renal function in Intensive Care Unit patients.
详细描述
Introduction: Administration of radiographic contrast agents often result in a reversible acute reduction in renal function that begins soon after contrast dye administration.
The incidence of contrast induced nephropathy varies from 5% to 50% depending on the patients' population and the criteria for contrast induced nephropathy (CIN), definition used and it is considered as one of the leading causes of hospital acquired acute renal failure.
The pathogenesis of contrast-induced nephropathy is uncertain. There are two main theories. According to the first one a possible influence on renal hemodynamics, mainly vasoconstriction, resulting in medullary ischemia possibly mediated by an alteration in endothelin and adenosine. In addition to direct vasoconstriction of renal vessels, iodinated contrast agents also block an important pathway for vasodilation and autoregulation possibly by reducing the production of nitric oxide. And according to the other main theory contrast agents exert direct toxic effects on tubular epithelial cells. It seems that reactive oxygen species have a role in CIN.
A lot of studies had examined the incidence of contrast agent-associated nephrotoxicity mainly in stable patients undergoing elective radiographic procedures.
Numerous agents have been examined for their ability to prevent contrast-induced decreases in renal function. Among them the use of low-osmolarity, non anionic contrast agents, and prophylactic hydration have reduced the incidence of CIN. Administration of drugs such as calcium antagonists, theophyllin, dopamine and atrial natriuretic peptide does not prevent CIN. In some studies antioxidant agents like acetylcysteine and ascorbic acid seem to reduce the incidence of CIN.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 14 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence in the Intensive Care Unit
- •Patients undergoing radiologic examinations with the use of IV contrast agents.
排除标准
- •Renal failure under renal replacement therapy
- •Unstable renal function ( change of serum creatinine between two subsequent days greater than 20% at least 3 days before the study)
- •IV administration of contrast agent within the previous 6 days from the study
- •Use of ascorbic acid or acetylcysteine during the week before the study
- •Pregnancy
研究组 & 干预措施
A. Experimental
1200mg acetylcysteine and 2g ascorbic acid at least 2 hours before the start of the index procedure, followed by 1200mg acetylcysteine and 1,5g ascorbic acid the night and the morning after the examination.
干预措施: N-acetylcysteine and ascorbic acid (Drug)
B. Control
200ml 0,9% normal saline IV
干预措施: N-acetylcysteine and ascorbic acid (Drug)
结局指标
主要结局
Morbidity in the Intensive Care Unit
时间窗: 1,5 year
次要结局
- Incidence of acute nephropathy after administration of radiocontrast agents(1,5 year)
