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IRCT20180515039674N1 IRCT 2018-09-04 Mashhad University of Medical Sciences The effect of anti-inflammatory formula to reduce inflammation in intensive care unit patients The effect of low Dietary Inflammatory Index formula on inflammatory and metabolic biomarkers in multiple trauma patients in Intensive Care Unit: a single blind randomized controlled trial 2018-06-21 anticipated 20 Complete https://irct.ir/trial/31178 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After selecting patients according to the inclusion criteria, they are matched according to age, sex, GCS and type of lesion, and randomly divided into one of two intervention and control groups. Patients will be randomly divided into intervention and control groups using statistical software and block randomization, Blinding description: After preparation of sachets (containing vitamins, salts and nutrients mentioned) by pharmaceutical specialist team and professors of the Pharmaceutical group and then adding it to the standard Enteralmeal formulas for formulation of the intervention group, both the formulas include the control group and the intervention is transferred to the hospital and In the hospital's kitchen after the preparation of the gavage solution in a same bottle as shape, numbered and encoded and transferred to the ICU and provided to the nurse concerned. N/A multiple truama. Intervention 1: Intervention group: To receive eternal formula (gavage) with low inflammation profile (anti-inflammation) for two weeks. Intervention 2: Control group: To receive standard eternal formula (gavage) for two weeks. Yes - There is a plan to make this available What will be shared: If necessary, the data will be unidentifiable and in accordance with the ethical standards existing at the deputy of research of the Faculty of Medical Sciences of Mashhad. When: After finishing the study and defending of the student's dissertation, the findings of the study will be published as a thesis and valid articles. To whom: All researchers in the field of health have the opportunity to use the findings of this study if they have written permission from the vice chancellor for research in Mashhad University of Medical Sciences. Conditions: After obtaining permission from the deputy of research of Mashhad University of Medical Sciences and the main executor of the project, further studies in this field will be available for the researchers. Where to obtain: Research Vice-President of Mashhad University of Medical Sciences, principal executor of the project (Dr. Mohammad Safarian, Associate Professor of Nutrition) How to obtain: Obtaining a written license from the Research Vice-President of Mashhad University of Medical Sciences, then referring to Mashhad University of Medical Sciences and obtaining permission from the principal moderator and head director of the nutrition department. Comments:
public Sajedeh Jandari
Department of Nutrition, Faculty of Medicine Mashhad University of Medical Sciences (MUMS) Paradise Daneshgah Azadi Square Post code 91779-48564 Mashad, Iran
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3882 7034 Jandaris951@mums.ac.ir Mashhad University of Medical Sciences scientific Mohammad Safarian
Department of Nutrition, Faculty of Medicine Mashhad University of Medical Sciences (MUMS) Paradise Daneshgah Azadi Square Post code 91779-48564 Mashad, Iran
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3800 2423 SafarianM@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) age between 18-65 Gastrointestinal tract with normal function and indications of Entral Nutrition Diagnosis of moderate to severe trauma based on GCS (4-14) 18 years 65 years Both failure to start enteral nutrition during the first 48 hours of admission Any history of cardiovascular disease Patients who are less than 96 hours in intensive care unit. Patients who are predicted to die within 12 hours of admission to the intensive care unit. Patients who are contraindicated for receiving enteral nutrition Patient dissatisfaction or their legal guardian S00-T98 Injury, poisoning and certain other consequences of external causes Treatment - Other Treatment - Other Intervention group: To receive eternal formula (gavage) with low inflammation profile (anti-inflammation) for two weeks. Control group: To receive standard eternal formula (gavage) for two weeks. Tumor necrosis factor-α. Timepoint: at the baseline, 7 and 14 days after intervention. Method of measurement: Enzyme-linked immunosorbent assay. Hs-CRP. Timepoint: at the baseline, 7 and 14 days after intervention. Method of measurement: Enzyme-linked immunosorbent assay. Alkaline phosphatase. Timepoint: At the baseline and 14 days after starting intervention. Method of measurement: Auto-analyzer. Aspartate Aminotransferase. Timepoint: At the baseline and 14 days after starting intervention. Method of measurement: Auto-analyzer. Alanine Aminotransferase. Timepoint: At the baseline and 14 days after starting intervention. Method of measurement: Auto-analyzer. Blood Glucose. Timepoint: At the baseline and 14 days after starting intervention. Method of measurement: Auto-analyzer. Triglyceride. Timepoint: At the baseline and 14 days after starting intervention. Method of measurement: Auto-analyzer. Mashhad University of Medical Sciences Approved 2018-05-14 Ethic committee of Mashhad University of Medical Sciences Department of Nutrition, Faculty of Medicine Mashhad University of Medical Sciences (MUMS) Paradise Daneshgah Azadi Square Post code 91779-48564 Mashad, Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)