Department of Clinical Pharmacy, Faculty of Pharmacy, Cairo University, Cairo, Egypt.
Department of Clinical Pharmacy, Faculty of Pharmacy, Cairo University, Cairo, Egypt.
Clin Ther. 2021 Jan;43(1):e1-e18. doi: 10.1016/j.clinthera.2020.11.008. Epub 2020 Dec 16.
Vitamin D deficiency is highly prevalent in critically ill patients, and has been associated with more prolonged length of hospital stay and poor prognosis. Patients undergoing open-heart surgery are at higher risk due to the associated life-threatening postoperative complications. This study investigated the effect of alfacalcidol treatment on the length of hospital stay in patients undergoing valve-replacement surgery.
This single-center, randomized, open-label, controlled trial was conducted at El-Demerdash Cardiac Academy Hospital (Cairo, Egypt), from April 2017 to January 2018. This study included adult patients undergoing valve-replacement surgery who were randomized to the intervention group (n = 47; alfacalcidol 2 μg/d started 48 h before surgery and continued throughout the hospital stay) or to the control group (n = 42). The primary end points were lengths of stay (LOS) in the intensive care unit (ICU) and in the hospital. Secondary end points were the prevalence of postoperative hospital-acquired infections, cardiac complications, and in-hospital mortality.
A total of 86 patients were included in the final analysis, with 51 (59.3%) being vitamin D deficient on hospital admission. Treatment with alfacalcidol was associated with a statistically significant decrease in ICU LOS (hazard ratio = 1.61; 95% CI, 1.77-2.81; P = 0.041) and hospital LOS (hazard ratio = 1.63; 95% CI, 1.04-2.55; P = 0.034). Treated patients had a significantly lower postoperative infection rate than did the control group (35.5% vs 56.1%; P = 0.017). The median epinephrine dose was lower in the intervention group compared to that in the control group (5.9 vs 8.2 mg; P = 0.019). The rate of in-hospital mortality was not significantly different between the 2 groups.
Early treatment with 2 μg of alfacalcidol in patients undergoing valve-replacement surgery is promising and well tolerated. This effect may be attributed to its immunomodulatory and cardioprotective mechanisms. ClinicalTrials.gov identifier: NCT04085770.
危重症患者普遍存在维生素 D 缺乏,且与住院时间延长和预后不良有关。由于术后危及生命的并发症,行心脏直视手术的患者风险更高。本研究旨在调查 AlfaCalcidol 治疗对行瓣膜置换术患者住院时间的影响。
这是一项于 2017 年 4 月至 2018 年 1 月在埃及开罗 El-Demerdash 心脏学院医院进行的单中心、随机、开放标签、对照试验。本研究纳入了行瓣膜置换术的成年患者,随机分为干预组(n=47;AlfaCalcidol 2μg/d,术前 48 小时开始,并持续整个住院期间)或对照组(n=42)。主要终点为 ICU 住院时间和总住院时间。次要终点为术后院内获得性感染、心脏并发症和院内死亡率的发生率。
共有 86 例患者纳入最终分析,入院时 51 例(59.3%)维生素 D 缺乏。AlfaCalcidol 治疗与 ICU 住院时间(风险比=1.61;95%CI,1.77-2.81;P=0.041)和总住院时间(风险比=1.63;95%CI,1.04-2.55;P=0.034)的显著降低相关。与对照组相比,治疗组术后感染率显著降低(35.5% vs 56.1%;P=0.017)。与对照组相比,干预组的肾上腺素剂量中位数较低(5.9 与 8.2mg;P=0.019)。两组的院内死亡率无显著差异。
在接受瓣膜置换术的患者中,早期使用 2μg AlfaCalcidol 治疗具有前景且耐受性良好。这种效果可能归因于其免疫调节和心脏保护机制。临床试验编号:NCT04085770。