Sahranavard Mehrdad, Hosseinjani Hesamoddin, Emadzadeh Maryam, Jamialahmadi Tannaz, Sahebkar Amirhossein
Biotechnology Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad, Iran.
Department of Clinical Pharmacy, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran.
Contemp Clin Trials Commun. 2024 Jun 18;40:101324. doi: 10.1016/j.conctc.2024.101324. eCollection 2024 Aug.
Improvement in organ failure in intensive care unit (ICU) patients is accompanied by lower mortality rate. A disaccharide, trehalose is a candidate to improve organ failure and survival by autophagy induction and enhancing oxidative stress defense. The aim of this study is to assess the effectiveness of trehalose in improving clinical outcome and reducing mortality in ICU patients.
a triple-blind, randomized, placebo-controlled, two arm, parallel-group, superiority clinical trial will enroll 200 ICU-admitted patients at Imam Reza hospital, Mashhad, Iran. The patients will be randomly allocated to receive either a 100 ml solution of 15 % trehalose or normal saline intravenously. Primary outcomes include ICU mortality and 60-day mortality, while secondary outcomes focus on blood parameters on day 5 and length of hospital/ICU stay.
Trehalose has demonstrated beneficial effects in diverse patients; however, no study has evaluated its effect in all ICU-admitted patients. Consequently, this study provides an opportunity to investigate whether trehalose's anti-inflammatory effects, mediated by inducing autophagy and enhancing oxidative stress defense, can play a role in reducing mortality and improving clinical outcomes in the critically ill patients. If successful, trehalose could offer a potential therapeutic approach in the ICU setting.
重症监护病房（ICU）患者器官功能衰竭的改善伴随着死亡率的降低。二糖海藻糖是一种有望通过诱导自噬和增强氧化应激防御来改善器官功能衰竭和提高生存率的物质。本研究的目的是评估海藻糖在改善ICU患者临床结局和降低死亡率方面的有效性。
一项三盲、随机、安慰剂对照、双臂、平行组、优效性临床试验将纳入伊朗马什哈德伊玛目礼萨医院200名入住ICU的患者。患者将被随机分配接受静脉注射100毫升15%海藻糖溶液或生理盐水。主要结局包括ICU死亡率和60天死亡率，次要结局关注第5天的血液参数以及住院/ICU住院时间。
海藻糖已在不同患者中显示出有益效果；然而，尚无研究评估其对所有入住ICU患者的影响。因此，本研究提供了一个机会，来探究海藻糖通过诱导自噬和增强氧化应激防御介导的抗炎作用，是否能在降低重症患者死亡率和改善临床结局方面发挥作用。如果成功，海藻糖可能为ICU环境提供一种潜在的治疗方法。
