multiple trauma. Unspecified multiple injuries
Conditions
Interventions
Intervention 1: Intervention group: Lactocar probiotic supplement (PO, 8 × 109 CFU/day probiotic, BID) + selenium supplement (intravenous sodium selenate, 1000 units/day). Intervention 2: Control grou
Sponsors
Tabriz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Intensive care unit admission due to multiple trauma APACHE score<30 Informed consent to participate in the study Serum selenium level below 70
Exclusion criteria
Exclusion criteria: Pregnant and breastfeeding women Patients with a history of diagnosed kidney, liver, or blood diseases Patients with a history of taking any probiotic or selenium supplements Patients with a history of receiving corticosteroids Patient's lack of consent to participate in the study at any stage of the study Receiving propofol due to its effect on serum lipid levels Receiving linezolid due to its effect on hematological factors Sepsis due to contraindications to probiotics in these patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum level of Interferon-?, Interleukin-17, Interleukin-1ß, Interleukin-4, Interleukin-6. Timepoint: Baseline and after 14 days of interventions. Method of measurement: Based on patients' serum samples. | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum oxidative stress factors include malondialdehyde, superoxide dismutase, glutathione peroxidase, total antioxidant capacity, catalase, reduced glutathione. Timepoint: Baseline and after 14 days of intervention. Method of measurement: Based on patients' serum samples.;Renal function based on BUN and Cr levels. Timepoint: Baseline and after 14 days of intervention. Method of measurement: Based on patients' serum samples.;Liver function based on serum levels of ALT, AST, and ALK.P. Timepoint: Baseline and after 14 days of intervention. Method of measurement: Based on patients' serum samples.;Blood factor status based on CBC. Timepoint: Baseline and after 14 days of intervention. Method of measurement: Based on patients' serum samples.;Lipid profile based on serum triglyceride and cholesterol levels, LDL and HDL. Timepoint: Baseline and after 14 days of intervention. Method of measurement: Based on patients' serum samples.;Inflammatory status based on hs-CRP, ferritin, and procalcitonin levels. Timepoint: Baseline and after 14 days of intervention. Method of measurement: Based on patients' serum samples.;Predictive criteria for death in intensive care unit patients (including APACHE II and SofaScore). Timepoint: Baseline and after 14 days of intervention. Method of measurement: Based on clinical examination.;Mortality of patients admitted to the intensive care unit (including ICU mortality, in-hospital mortality, and 28-day mortality). Timepoint: Baseline and after 14 days of intervention. Method of measurement: Based on the patients' clinical records.;Occurrence of ventilator-associated respiratory and urinary tract infections. Timepoint: End of intensive care unit admission, end of hospital stay, and at 28-day follow-up. Method of measurement: Based on the patients' clinical records and follow-up.;Length of stay in the intensive care unit and hospital. Timepoint: End of intensive care unit admission, end of hospital admission. Method of measurement: Based on the | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Sarvin Sanaie
Tabriz University of Medical Sciences
Outcome results
None listed