The Effects of Highdose Selenium Supplementation on the Oxidative Stress Status and Inflammatory Markers in Critically Ill Pediatric Patients after Gastrointestinal Surgery: A Randomized Clinical Trial Protocol Study

Introduction: Oxidative stress and inflammation could occur after major gastrointestinal surgeries. Selenium is a micronutrient with antiinflammatory and antioxidant properties, which could improve the inflammatory markers in the children admitted to the intensive care unit (ICU) after gastrointestinal surgeries. Due to the lack of evidence on the potential effects of highdose selenium on postsurgical critically ill children, the present study aimed to evaluate the effects of highdose selenium supplementation on the levels of inflammatory markers and oxidative stress status in pediatric patients after gastrointestinal surgery. Methods and analysis: We will conduct a singleblinded, randomized, parallel group superiority trial at Akbar Pediatrics Hospital in Mashhad, Iran. The sample population will consist of 70 patients undergoing gastrointestinal surgery, who will admit to the ICU at the selected hospital. The control group will receive the recommended dietary allowance (RDA) doses of selenium, and the intervention group will receive 20 µg/kg/d of selenium. The primary outcomes, (the prooxidantantioxidant balance (PAB) status, interleukin1 beta (IL1β), and highsensitivity Creactive protein (hsCRP)) will be measured before surgery and upon discharge time. The secondary outcomes, (serum glutathione peroxidase (GPX) level and serum and urine selenium levels), will be measured before surgery, after surgery, and upon ICU discharge time. We will perform the intragroup and intergroup data analysis in SPSS software, and we will consider the intentiontotreat approach, statistical significance level of lt;0.05, and 95% confidence interval in all the statistical analyses.