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Evaluation of the effect of high dose intravenous vitamin C on delayed allograft function in deceased donor kidney transplantation: a preliminary report

机译:高剂量静脉维生素C对死亡肾移植延迟同种异体移植功能的评价:初稿

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Delayed graft function (DGF) can affect short- and long-term allograft outcomes in kidney transplant recipients. One of the pathophysiological pathways in the occurrence of DGF is ischemia-reperfusion injury (IRI). High dose intravenous vitamin C has proven efficacy in decreasing IRI consequences. Accordingly, we designed this study to assess the effect of high dose intravenous vitamin C on the incidence and duration of DGF. This is a pilot, single-center, double-blinded, randomized, placebo-controlled trial. In the treatment group, kidney transplant recipients received vitamin C infusion at the dose of 70?mg/kg diluted in 0.45% saline, and in another study arm, only the diluent solution was administered. Data regarding allograft function and other clinical information was recorded. This preliminary study on 19 patients (9 cases in the vitamin C and 10 cases in the placebo group) showed that after administration of single, high dose vitamin C the incidence of DGF was not significantly different between the groups, but the duration of DGF was substantially shorter in the vitamin C group than the placebo group (7.33 ± 5.68 versus 19.66 ± 0.57?days; P = 0.02). Acute rejection episodes were more seen in the vitamin C group than in the placebo group. Although this data was not statistically significant (P = 0.37), it led to the termination of the study. A high dose of intravenous vitamin C before allograft implantation was effective in decreasing DGF duration but not DGF incidence. The trial was registered in the Iranian registry of clinical trials encoded IRCT20100111003043N13 on June 24, 2019.
机译:延迟接枝函数(DGF)可以影响肾移植受者的短期和长期同种异体移植结果。 DGF发生的病理生理途径之一是缺血再灌注损伤(IRI)。高剂量静脉维生素C已在降低IRI后果中经过验证的功效。因此,我们设计了该研究,以评估高剂量静脉维生素C对DGF的发生率和持续时间的影响。这是一个试点,单中心,双盲,随机,安慰剂对照试验。在治疗组中,肾移植受者在0.45%盐水中稀释的70×mg / kg的剂量,在另一项研究臂中施用维生素C输注,仅施用稀释剂溶液。记录了关于同种异体移植函数和其他临床信息的数据。这项初步研究19例患者(安慰剂组维生素C和10例患者9例)表明,在施用单一时,高剂量维生素C在组之间的发生率没有显着差异,但DGF的持续时间是维生素C组大致短于安慰剂组(7.33±5.68与19.66±0.57?天; P = 0.02)。维生素C组中比安慰剂组更常见的急性排斥发作。虽然这种数据没有统计学意义(P = 0.37),但它导致了研究的终止。同种异体移植植入前的高剂量静脉内维生素C可有效降低DGF持续时间但不是DGF入射。该试验在2019年6月24日编制IRCT20100111003043N13的临床试验中注册了伊朗登记。

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