Cameron Lynda Katherine, Lei Katie, Smith Samantha, Doyle Nanci Leigh, Doyle James F, Flynn Kate, Purchase Nicola, Smith John, Chan Kathryn, Kamara Farida, Kidane Nardos Ghebremedhin, Forni Lui G, Harrington Dominic, Hampson Geeta, Ostermann Marlies
Biomedical Research Centre,Guy's and St Thomas' NHS Foundation Trust, London, UK.
Florence Nightingale Faculty of Nursing and Midwifery, King's College London, London, UK.
BMJ Open. 2017 Jul 12;7(7):e016486. doi: 10.1136/bmjopen-2017-016486.
Acute kidney injury (AKI) affects more than 50% of critically ill patients. The formation of calcitriol, the active vitamin D metabolite, from the main inactive circulating form, 25-hydroxyvitamin D (25(OH)D), occurs primarily in the proximal renal tubules. This results in a theoretical basis for reduction in levels of calcitriol over the course of an AKI. Vitamin D deficiency is highly prevalent in critically ill adults, and has been associated with increased rates of sepsis, longer hospital stays and increased mortality. The primary objective of this study is to perform serial measurements of 25(OH)D and calcitriol (1,25(OH)D), as well as parathyroid hormone (PTH) and fibroblast growth factor 23 (FGF23) levels, in critically ill adult patients with and without AKI, and to determine whether patients with AKI have significantly lower vitamin D metabolite concentrations. The secondary objectives are to describe dynamic changes in vitamin D metabolites, PTH and FGF23 during critical illness; to compare vitamin D metabolite concentrations in patients with AKI with and without renal replacement therapy; and to investigate whether there is an association between vitamin D status and outcomes.
230 general adult intensive care patients will be recruited. The AKI arm will include 115 critically ill patients with AKI Kidney Disease Improving Global Outcome stage II or stage III. The comparison group will include 115 patients who require cardiovascular or respiratory support, but who do not have AKI. Serial measurements of vitamin D metabolites and associated hormones will be taken on prespecified days. Patients will be recruited from two large teaching Trusts in England. Data will be analysed using standard statistical methods.
Ethical approval was obtained. Upon completion, the study team will submit the study report for publication in a peer-reviewed scientific journal and for conference presentation.
NCT02869919; Pre-results.
急性肾损伤（AKI）影响超过50%的重症患者。活性维生素D代谢产物骨化三醇由主要的非活性循环形式25-羟基维生素D（25(OH)D）形成，主要发生在近端肾小管。这为急性肾损伤过程中骨化三醇水平降低提供了理论依据。维生素D缺乏在重症成人中非常普遍，并且与败血症发生率增加、住院时间延长和死亡率增加有关。本研究的主要目的是对有和没有急性肾损伤的重症成年患者进行25(OH)D和骨化三醇（1,25(OH)D）以及甲状旁腺激素（PTH）和成纤维细胞生长因子23（FGF23）水平的系列测量，并确定急性肾损伤患者的维生素D代谢产物浓度是否显著降低。次要目的是描述重症疾病期间维生素D代谢产物、PTH和FGF23的动态变化；比较接受和未接受肾脏替代治疗的急性肾损伤患者的维生素D代谢产物浓度；并研究维生素D状态与预后之间是否存在关联。
将招募230名成年普通重症监护患者。急性肾损伤组将包括115名患有急性肾损伤改善全球肾脏病预后组织（KDIGO）II期或III期的重症患者。对照组将包括115名需要心血管或呼吸支持但没有急性肾损伤的患者。将在预定日期对维生素D代谢产物和相关激素进行系列测量。患者将从英国的两个大型教学信托机构招募。数据将使用标准统计方法进行分析。
已获得伦理批准。研究完成后，研究团队将提交研究报告以在同行评审的科学期刊上发表并在会议上展示。
NCT02869919；预结果。
