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IRCT20190122042449N1 IRCT 2019-01-27 Mashhad University of Medical Sciences effect of selenium on oxidative stress status and inflammatory factors in post gastrointestinal surgery children Evaluation of the effect of high doses of selenium on oxidative stress status and inflammatory factors in post gastrointestinal surgery children in intensive care unit 2019-02-06 anticipated 70 Complete https://irct.ir/trial/37008 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Method of randomization : block Unit of randomization : individual Randomization strata in stratified randomization: age (>/< 1 year) and surgery (upper/ lower GI) Tools used in randomization: table of random numbers Allocation concealment will carried out, Blinding description: With the exception of a pharmacist,corresponding physician and investigator the supplement/ placebo assignment will be concealed from the patients, nursing system, data analyser and safety monitoring board throughout the study. 3 Condition 1: Digestive System Surgical Procedures. Condition 2: selenium deficiency. Condition 3: Congenital diaphragmatic hernia. Condition 4: Acute abdomen. Condition 5: Congenital malformations of esophagus. Condition 6: Other specified congenital malformations of upper alimentary tract. Condition 7: Congenital disorders of small intestine. Condition 8: Congenital disorders of large intestine. Condition 9: Congenital malformations of gallbladder, bile ducts and liver. Intervention 1: Intervention group: Selenium supplementation will continue to be given at a dose of 20 μg / kg / d for 10 days or until discharge from the intensive care unit or death. High-dose selenium content will be injected intravenously 20 cc of dextrose 5% in 60 minutes. Injectable selenium in sodium selenite form with a concentration of 50 μg / ml by the Pharmacy school of Mashhad University of Medical Sciences will be used. Intervention 2: Control group: The placebo(serum: dextrose 5% ) with the same volume and shape as the intervention group, for 10 days or until discharge from the intensive care unit or death. Yes - There is a plan to make this available What will be shared: The non-identifiable individual participant data collected in this study will be shared. Also, The protocol, results, and statistical analysis of the current study will be published in the relevant articles. When: The non-identifiable individual participant data will become available after the publication of the relevant articles. To whom: they will be available for people working in academic institutions and people working in businesses can also apply to receive it. Conditions: The non-identifiable individual participant data can only be used for research. Where to obtain: The non-identifiable individual participant data will be obtainable by sending an e-mail to Dr. Mohsen Nematy. ( e-mail address: NematyM@mums.ac.ir) How to obtain: Other researchers in academic institutions can send their request by e-mail to Dr. Mohsen Nematy. The data will be sent to them after consulting and approving the research team. Comments:
public Fatemeh Roudi
Mashhad University of Medical Sciences (MUMS) Campus of University (Paradise Daneshgah), Azadi Square
Mashhad Iran (Islamic Republic of) 91779-48564 +98 51 3800 2423 roudif951@mums.ac.ir Mashhad University of Medical Sciences scientific Fatemeh Roudi
Mashhad University of Medical Sciences (MUMS) Campus of University (Paradise Daneshgah), Azadi Square
Mashhad Iran (Islamic Republic of) 91779-48564 +98 51 3800 2423 roudif951@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) 0-10 years old patients undergoing major gastrointestinal surgery at the Akbar Hospital of Mashhad Admission to the intensive care unit due to medical indications Filling out the informed consent form by a parent or legal guardian Stability of hemodynamic and metabolic status in the first 24 to 48 hours 1 day 10 years Both Patients who are not allowed to start a nutrition support care for them within the first 24-48 hours Diagnosed autoimmune disorders Diagnosed cancers Severe sepsis at the admission time History of chemotherapy and radiotherapy in the past month Diagnosed renal failure Diagnosed severe hepatic failure Severe and active bleeding A known case of human immunodeficiency virus Preterm neonates K56.60 E64.8 Q79.0 R10.0 Q39 Q40 Q41 Q42 Q44 Unspecified intestinal obstruction Sequelae of other nutritional deficiencies Congenital diaphragmatic hernia Acute abdomen Congenital malformations of esophagus Other congenital malformations of upper alimentary tract Congenital absence, atresia and stenosis of small intestine Congenital absence, atresia and stenosis of large intestine Congenital malformations of gallbladder, bile ducts and liver Treatment - Other Placebo Intervention group: Selenium supplementation will continue to be given at a dose of 20 μg / kg / d for 10 days or until discharge from the intensive care unit or death. High-dose selenium content will be injected intravenously 20 cc of dextrose 5% in 60 minutes. Injectable selenium in sodium selenite form with a concentration of 50 μg / ml by the Pharmacy school of Mashhad University of Medical Sciences will be used. Control group: The placebo(serum: dextrose 5% ) with the same volume and shape as the intervention group, for 10 days or until discharge from the intensive care unit or death. Pro-oxidant- Antioxidant Balance (PAB) status. Timepoint: before intervention and after 10 days. Method of measurement: Pro-oxidant- Antioxidant Balance (PAB) assay. Inflammatory factors. Timepoint: before intervention and after 10 days. Method of measurement: Interleukin 1 beta: ELISA, high-sensitivity C-reactive protein (hs-CRP) test: Immunoturbidimetry. Serum and urine selenium Level. Timepoint: before intervention and 1, 10 days after intervention. Method of measurement: atomic absorpsion. Serum Glutathione peroxidase level. Timepoint: before intervention and 1, 10 days after intervention. Method of measurement: ELISA. Mashhad University of Medical Sciences Approved 2018-12-18 Ethics committee of Mashhad University of Medical Science Campus of University (Paradise Daneshgah), Azadi Square Mashhad Razavi Khorasan Iran (Islamic Republic of)