To evaluate effects of genistein supplementation to enteral nutrition on inflammatory cytokines and morbidity in patients with sepsis
Sepsis is a state develops as a response to severe infection with high mortality rate. Incidence of sepsis among patients admitted to hospitals is 2%. Annual incidence of sepsis is 50-95 for 100.000 population and incidence is increasing approximately 9% each year. Severe sepsis and septic shock is the most frequent reason for mortality in intensive care units (ICU). There is exaggerated and irregular host response in sepsis. Cytokines such as interleukin-1, interleukin-6, interleukin-8, tumor necrosis factor-α, Interferon-γ and high mobility group box-1 are released as response to invading microorganisms and they play a major role in sepsis pathogenesis. Soybean proteins are used for prevention and treatment of cardiovascular diseases, osteoporosis and different cancer types. Soy isoflavones such as genistein, daidzein and glycitein are the main components for cancer prevention. Genistein is the dominant isoflavones. The main mechanism for anti-inflammatory effect of genistein is related to transcription nuclear factor (NF-kB) and inhibition of chemokine-8. The risk for prostate cancer was proven to decrease in epidemiological studies. NF-kB plays a central role for inflammatory cytokine release, prevents apoptosis and induces tumor cell growth. The effect of topoisomerase II inhibitory chemotherapeutic agents is increased with NF-kB inhibition. Hypothesis 1. Addition of genistein to enteral nutrition in patients with sepsis can play an important role to decrease inflammatory cytokines. 2. Morbidity can be decreased with lower levels of inflammatory cytokines in patients with sepsis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Total 30 patients will be included into the study They will be divided into two groups each containing 15 patients. Intervention group will receive supplemental genistein (60 mg/day) to enteral nutrition
These are the patients receiving enteral nutrition
Erciyes University Medical School
Kayseri, Turkey (Türkiye)
RECRUITINGChange in Tumor necrosis factor alpha serum levels
It will be measured at baseline, at 24th hour and at 72nd hour after inclusion into the study
Time frame: Baseline, at 24th hour and at 72nd hour
Change in interleukin 1-beta serum levels
It will be measured at baseline, at 24th hour and at 72nd hour after inclusion into the study
Time frame: Baseline, at 24th hour and at 72nd hour
Change in interleukin 6 serum levels
It will be measured at baseline, at 24th hour and at 72nd hour after inclusion into the study
Time frame: Baseline, at 24th hour and at 72nd hour
Change in high-mobility group box 1 serum levels
It will be measured at baseline, at 24th hour and at 72nd hour after inclusion into the study
Time frame: Baseline, at 24th hour and at 72nd hour
Number of study participants with development of new pneumonia, urinary tract infection and blood stream infections
Patients will be followed until they are discharged from the hospital or death.
Time frame: From date of randomization until 12 weeks
Length of intensive care unit and hospital stay (days)
Patients will be followed until they are discharged from the hospital or death.
Time frame: From date of randomization until 12 weeks
Duration of mechanical ventilation
Patients will be followed until they are discharged from the hospital or death.
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Time frame: From date of randomization until 12 weeks
Intensive care unit mortality rate, hospital mortality rate
Patients will be followed until they are discharged from the hospital or death.
Time frame: From date of randomization until 12 weeks