Sepsis
Conditions
Keywords
Enteral nutrition, Genistein, Cytokine
Brief summary
To evaluate effects of genistein supplementation to enteral nutrition on inflammatory cytokines and morbidity in patients with sepsis
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTGenistein
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
Sponsors
TC Erciyes University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Criteria: inclusion criteria: * Patients with sepsis above 18 years of age. * Expected duration of ICU survival more than 48 hours. * Patients receiving enteral nutrition (EN) * Sepsis diagnosis within first 12 hours
Exclusion criteria
* Presence of thyroid dysfunction * Presence of hyperlipidemia * Patients with nill by mouth and not receiving enteral nutrition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in high-mobility group box 1 serum levels | 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 Tumor necrosis factor alpha serum levels | 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 | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of study participants with development of new pneumonia, urinary tract infection and blood stream infections | From date of randomization until 12 weeks | Patients will be followed until they are discharged from the hospital or death. |
| Length of intensive care unit and hospital stay (days) | From date of randomization until 12 weeks | Patients will be followed until they are discharged from the hospital or death. |
| Duration of mechanical ventilation | From date of randomization until 12 weeks | Patients will be followed until they are discharged from the hospital or death. |
| Intensive care unit mortality rate, hospital mortality rate | From date of randomization until 12 weeks | Patients will be followed until they are discharged from the hospital or death. |
Countries
Turkey (Türkiye)
Contacts
Primary ContactKursat Gundogan, MD
Backup ContactMurat Sungur, MD
Outcome results
None listed