Effect of Enteral Genistein Supplementation in Sepsis
Λέξεις-κλειδιά
Αφηρημένη
Περιγραφή
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.
Ημερομηνίες
| Τελευταία επαλήθευση: | 05/31/2016 |
| Πρώτα υποβλήθηκε: | 03/09/2016 |
| Υποβλήθηκε εκτιμώμενη εγγραφή: | 06/06/2016 |
| Δημοσιεύτηκε για πρώτη φορά: | 06/12/2016 |
| Υποβλήθηκε τελευταία ενημέρωση: | 06/06/2016 |
| Δημοσιεύτηκε η τελευταία ενημέρωση: | 06/12/2016 |
| Ημερομηνία έναρξης της πραγματικής μελέτης: | 05/31/2015 |
| Εκτιμώμενη κύρια ημερομηνία ολοκλήρωσης: | 08/31/2016 |
| Εκτιμώμενη ημερομηνία ολοκλήρωσης μελέτης: | 08/31/2016 |
Κατάσταση ή ασθένεια
Παρέμβαση / θεραπεία
Dietary Supplement: Genistein
Other: control
Φάση
Ομάδες βραχιόνων
| Μπράτσο | Παρέμβαση / θεραπεία |
|---|---|
| Active Comparator: Genistein Intervention group will receive supplemental genistein (60 mg/day) to enteral nutrition | Dietary Supplement: Genistein 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 |
| Other: control Control group are the patients receiving enteral nutrition | Other: control These are the patients receiving enteral nutrition |
Κριτήρια καταλληλότητας
| Επιλέξιμες ηλικίες για μελέτη | 18 Years Προς την 18 Years |
| Φύλα επιλέξιμα για μελέτη | All |
| Δέχεται υγιείς εθελοντές | Ναί |
| Κριτήρια | 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 |
Αποτέλεσμα
Πρωτεύοντα αποτελέσματα
1. Change in Tumor necrosis factor alpha serum levels [Baseline, at 24th hour and at 72nd hour]
2. Change in interleukin 1-beta serum levels [Baseline, at 24th hour and at 72nd hour]
3. Change in interleukin 6 serum levels [Baseline, at 24th hour and at 72nd hour]
4. Change in high-mobility group box 1 serum levels [Baseline, at 24th hour and at 72nd hour]
Δευτερεύοντα αποτελέσματα
1. Number of study participants with development of new pneumonia, urinary tract infection and blood stream infections [From date of randomization until 12 weeks]
2. Length of intensive care unit and hospital stay (days) [From date of randomization until 12 weeks]
3. Duration of mechanical ventilation [From date of randomization until 12 weeks]
4. Intensive care unit mortality rate, hospital mortality rate [From date of randomization until 12 weeks]
