Effect of Enteral Genistein Supplementation on Inflammatory Cytokines, Morbidity and Mortality in Patients With Sepsis
试验速览
- 阶段
- 4 期
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in Tumor necrosis factor alpha serum levels
研究概览
简要总结
To evaluate effects of genistein supplementation to enteral nutrition on inflammatory cytokines and morbidity in patients with sepsis
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Presence of thyroid dysfunction
- •Presence of hyperlipidemia
- •Patients with nill by mouth and not receiving enteral nutrition
结局指标
主要结局
Change in Tumor necrosis factor alpha serum levels
时间窗: Baseline, at 24th hour and at 72nd hour
It will be measured at baseline, at 24th hour and at 72nd hour after inclusion into the study
Change in high-mobility group box 1 serum levels
时间窗: Baseline, at 24th hour and at 72nd hour
It will be measured at baseline, at 24th hour and at 72nd hour after inclusion into the study
Change in interleukin 1-beta serum levels
时间窗: Baseline, at 24th hour and at 72nd hour
It will be measured at baseline, at 24th hour and at 72nd hour after inclusion into the study
Change in interleukin 6 serum levels
时间窗: Baseline, at 24th hour and at 72nd hour
It will be measured at baseline, at 24th hour and at 72nd hour after inclusion into the study
次要结局
- Duration of mechanical ventilation(From date of randomization until 12 weeks)
- Number of study participants with development of new pneumonia, urinary tract infection and blood stream infections(From date of randomization until 12 weeks)
- Length of intensive care unit and hospital stay (days)(From date of randomization until 12 weeks)
- Intensive care unit mortality rate, hospital mortality rate(From date of randomization until 12 weeks)
研究者
Kursat Gundogan
MD
TC Erciyes University