Sepsis. Other sepsis
Conditions
Interventions
Intervention 1: Intervention group: In addition to standard treatment, this group of patients will receive 1 mg of colchicine orally every 12 hours for 5 days (25 patients). Intervention 2: Control gr
Sponsors
Hamedan University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: septic patients admitted to the ICU(diagnosed according to sepsis 3-criteria) Age over 18years Providing written informed consent Having conditions for enteral nutrition
Exclusion criteria
Exclusion criteria: Pregnant women Individuals with very low body waight (body mass index(BMI)<18/5kg/m2) Patents requiring frequent blood transfusions Patients with septic shock and those patients who experience unwanted side effects after taking supplement or placebo will be excluded from the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NUTRIC Score. Timepoint: Day 1 and day5. Method of measurement: Measure using the modified NUTRIC (mNUTRIC) score, which assesses nutrition risk based on clinical data excluding interleukin-6 levels. The score is calculated from variables such as age, APACHE II score, SOFA score, number of comorbidities, and days from hospital to ICU admission. Data are collected from patient records and clinical assessment.;SOFA Score. Timepoint: Day 1 and Day 5. Method of measurement: Clinical and laboratory parameters including PaO2/FiO2 ratio, platelet count, bilirubin, mean arterial pressure, Glasgow Coma Scale, creatinine, and urine output.;APACHE II. Timepoint: Day 1 and Day 5. Method of measurement: Measure physiological parameters including temperature, mean arterial pressure, heart rate, respiratory rate, oxygenation (PaO2/FiO2), sodium, potassium, creatinine, hematocrit, white blood cell count, Glasgow Coma Scale, and arterial pH. Each parameter is scored and summed using the APACHE II scoring system to assess illness severity.;C-reactive protein (CRP). Timepoint: Day 1 and Day 5. Method of measurement: Measure CRP concentration from a venous blood sample using standard laboratory immunoassays. Blood is drawn from the arm vein, and CRP levels are quantified to assess inflammation.;Erythrocyte Sedimentation Rate (ESR). Timepoint: Day 1 and Day 5. Method of measurement: Measure ESR using the Westergren method: anticoagulated venous blood is drawn into a Westergren tube, placed vertically at room temperature, and the distance of red cell sedimentation is measured after 1 hour in millimeters (mm/hr). | — |
Secondary
| Measure | Time frame |
|---|---|
| 28-day Mortality Rate. Timepoint: Day 28. Method of measurement: Measure by recording patient survival status 28 days after ICU admission or study enrollment through hospital records or follow-up. Mortality is expressed as the proportion of patients deceased within 28 days.;TAC (Total Antioxidant Capacity). Timepoint: Day 1 and Day 28. Method of measurement: Measure TAC using an automated assay involving mixing the sample with a crocin reagent, incubation, addition of an oxidizing agent, and absorbance measurement at a preset wavelength. TAC is calculated by comparing absorbance to a standard curve.;MDA (Malondialdehyde). Timepoint: Day 1 and Day 28. Method of measurement: Measure MDA as a marker of lipid peroxidation typically via thiobarbituric acid reactive substances (TBARS) assay in plasma or serum samples using spectrophotometry or HPLC methods.;SOD (Superoxide Dismutase). Timepoint: Day 1 and Day 28. Method of measurement: Measure SOD enzyme activity in blood or tissue samples using spectrophotometric assays that quantify the dismutation of superoxide radicals. Commercial kits are commonly used. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactKiumath Amini
Hamedan University of Medical Sciences
Outcome results
None listed