Trauma / head injury. Intracranial injury that involves brain damage.
Conditions
Interventions
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
Sponsors
Mashhad University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMoazzameh Ghorbani Dehbalaei
Mashhad University of Medical Sciences
Outcome results
None listed