Effect of trehalose on mortality and disease severity in ICU-admitted patients: Protocol for a triple-blind, randomized, placebo-controlled clinical trial.

Background: 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. Methods: 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. Conclusion: 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.