The effect of low Dietary Inflammatory Index formula on inflammatory and metabolic biomarkers in multiple trauma patients in Intensive Care Unit: a double blind randomized controlled trial

Determination of the Effect of Formula with Low Inflammatory index on Inflammatory and Metabolic Factors in Multiple Trauma Patients Admitted to Shahid Kamyab Hospital in Mashhad

In this study, 20 adult patients aged 18-65 years old with a general trauma after admission to ICU were selected according to the inclusion criteria and matched according to age, sex, type of lesions, GCS and randomly will be inter into two groups . The sampling method is not randomly (based on the purpose and according to the inclusion criteria and exclusion criteria). The method of collecting information is in a laboratory and observational tool.

In this study, 20 adult patients aged 18-65 years old were included 24-48 hours after being admitted to the intensive care unit of Shahid Kamyab Hospital in Mashhad based on inclusion criteria and randomly divided into two groups.

Inclusion criteria: age between 18-65 Gastrointestinal tract with normal function and indications of Enteral Nutrition Diagnosis of moderate to severe trauma based on GCS (4-14) Exclusion criteria: 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

Receiving enteral formula gavage with low inflammatory index (anti-inflammation) for 2 weeks in case group and receiving standard gavage for 2 weeks in control group.

IL-1β, IL-4, IL-6, IL-10, hs-CRP, TNF-α ALT, AST, ALP BG HDL-c, LDL-c, Total cholesterol, TG

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.

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.

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.

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.

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.

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.

Research Vice-President of Mashhad University of Medical Sciences, principal executor of the project (Dr. Mohammad Safarian, Associate Professor of Nutrition)

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.