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IRCT20210508051223N1 IRCT 2021-07-26 Mashhad University of Medical Sciences Evaluation of the effect of oral trehalose in patients with traumatic head injury in ICU Evaluation of the effect of oral trehalose on inflammatory factors, oxidative stress and nutritional and clinical status in patients with traumatic head injury receiving enteral nutrition- a pilot study 2022-05-22 anticipated 20 Complete https://irct.ir/trial/56253 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is performed by stratified permuted block randomization method, with block size equal to 4. The allocation ratio is 1:1. Using the site www.sealedenvelope.com, a random sequence of five blocks will be generated, each containing four patients. The classification is based on age (18-65), gender (Male/Female), and APACHE II score (0 to 35 and 35 to 71) using quadruple blocks. The specific code for the participants and their treatment group is placed in different envelopes from 1 to 20. Upon the arrival of each eligible volunteer, informed consent will be obtained and then the first envelope will be opened, and its treatment group is determined. Allocation concealment will be considered using opaque-sealed sequentially numbered envelopes, Blinding description: For proper blindness, the drug and placebo will be exactly the same in color, size, and odor. 2-3 Trauma / head injury. Intracranial injury that involves brain damage. Intervention 1: The intervention group: During 12 days, patients in the intervention group will receive 30 grams of trehalose instead as a part of the carbohydrate of daily gavage. Their gavages will be administered by the bolus method. Intervention 2: The control group: will receive standard isocaloric hospital gavage over 12 days. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Moazzameh Ghorbani Dehbalaei
Baharestan Dormitory No. 1, Bahonar Boulevard, Vakil-Abad Boulevard
Mashhad Iran (Islamic Republic of) 9177948959 +98 51 3800 2214 ghorbanidm981@mums.ac.ir Mashhad University of Medical Sciences scientific Dr. Abdolreza Norouzi
Baharestan Dormitory No. 1, Bahonar Boulevard, Vakil-Abad Boulevard
Mashhad Iran (Islamic Republic of) 9177948959 +98 51 3800 2214 NorouzyA@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Critically ill TBI patients admitted to ICU Stable hemodynamic and metabolic conditions in the first 24-48 h GCS≥7 Having antral feeding Lack of intolerance to food sources containing trehalose such as mushroom Willingness to cooperate and sign the informed consent form after full knowledge of the objectives and method of the study by the individual or legal guardian 18 year ≤ age ≤ 65 year 18 years 65 years Both Patients with head trauma who have been on Nil Per Os (NPO) for more than 48 hours (not allowed to receive food). Head trauma patients receiving parenteral nutrition (TPN). Patients who are transferred from other ICUs after 1 week. Having a history of cancer, autoimmune diseases, and congenital metabolic diseases. Pregnancy and lactation. Treatment - Other N/A The intervention group: During 12 days, patients in the intervention group will receive 30 grams of trehalose instead as a part of the carbohydrate of daily gavage. Their gavages will be administered by the bolus method The control group: will receive standard isocaloric hospital gavage over 12 days. Serum level changes of c-reactive protein (CRP). Timepoint: At the beginning of the study, 6th, and 12th day. Method of measurement: Special measuring kit. Serum level changes of Interleukin 6 (IL-6). Timepoint: At the beginning of the study, 6th, and 12th day. Method of measurement: Special measuring kit. Serum level changes of Malondialdehyde (MDA). Timepoint: At the beginning of the study, 6th, and 12th day. Method of measurement: Special measuring kit. Serum level changes of superoxide dismutase (SOD). Timepoint: At the beginning of the study, 6th, and 12th day. Method of measurement: Special measuring kit. Serum level changes of total antioxidant capacity (TAC). Timepoint: At the beginning of the study, the 6th, and 12th day. Method of measurement: Special measuring kit. Pro oxidant antioxidant balance (PAB) in the Serum level. Timepoint: At the beginning of the study, 6th, and 12th day. Method of measurement: Laboratory testing with a previously known scientific method. Serum level changes of Glutathione (GSH) changes. Timepoint: At the beginning of the study, 6th, and 12th day. Method of measurement: Special measuring kit. Blood sugar. Timepoint: Daily. Method of measurement: Glucometer. Blood pressure. Timepoint: Daily. Method of measurement: Barometer. Lipid profile. Timepoint: Weekly. Method of measurement: Special kit. Sequential Organ Failure Assessment (SOFA) criteria. Timepoint: Daily. Method of measurement: Questionnaire. The Acute Physiology and Chronic Health Evaluation (APACHE II) criteria. Timepoint: At the beginning of the study ,6th, and 12th day. Method of measurement: APACHE II questionnaire. Glasgow Coma Scale (GCS). Timepoint: Daily. Method of measurement: Questionnaire (Scoring system). 28-day mortality. Timepoint: 28 days after admission to the ICU. Method of measurement: Check the patient's hospital electronic file information or check the patient's mortality by telephone. Nutrition Risk in the Critically ill score (NUTRIC score). Timepoint: At the beginning of the study ,6th, and 12th day. Method of measurement: Questionnaire. Mashhad University of Medical Sciences Approved 2021-05-31 Ethics Committee of Mashhad University of Medical Sciences Deputy of Research and Technology, Ghorashi Building, next to Hoveyzeh Cinema, Dneshgah Street Mashhad Razavi Khorasan Iran (Islamic Republic of)