Cardiac valvular disease, coronary artery disease Cardiac valvular disease, coronary disease
Conditions
Interventions
Symbiotics (LBG-P) will be administered from 10 days before surgery to one day bedore surgery three times per day. If the surgery is prolonged, LBG-P is administered for 14 days preoperativelsy. After
symbiotics,
Sponsors
Yoshitani Kenji
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients with elective cardiac surgery with cardiopulmonary bypass 2)Patietns with entry more than 10 days before surgery 3)Patients more than 65 years old. 4)Patients with informed consent by myself
Exclusion criteria
Exclusion criteria: 1) Patients who cannot stop taking other supplement such as symbaiotics or probiotics during test period. 2) Patents with preoperative ICDSC no more than 3, or MMSE no less than 21 3) Patients who cannot take test symbiotics or placebo due to allegry or diffulty of oral ingestion. 4) Patients with left ventricle assist device. 5) Patient with corticobasal degeneration disease. 6) Patients with history of craniotomy 7) Patients with antipsychotic agent 8) Patients who is diagnosed as dimentia and received standard therapy 9) Patiemts daignosed as infectious myocarditis 10) Patients with stoma 11) Patients diagnosed as inflammatory bowel disease(Crohn disease, ulcerative colitis) and receiving standard therapy 12) Patients diagnosed as collagen disease and receiving standard therapy 13) Patients receiving antibiotics within 2 weeks prior to obtaining consen. 14) Patients participating other clinical traial or shceduled to be enrolled in the other clinical trial. 15) Patients deemed to be unsuitable to be enrolled into this study due to other specific reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Association between symbiotics and the incidence of postoperative delirium (ICDSC score of 3 or higher is defined as delirium) in postoperative one week | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Incidence of postoparative major adverse cardiac evnet (Cardiac index no less than 2.2L/min/m2, death due to cardiac and vascular events, nonlethal miyocardial infarction, unstable angina, stroke, deteriolation of heart failure, new onset atrial fibrillation) within 3 months 2)Incidence of postoperative pneumonia within one month 3)Incidence of reintubation more than 6 hours after extubation in hospital 4)Incidence and duration of postoperative surgical site Infection within three months which requires antibiotics therapy 5)Incidnce of acute kidney injury within three months diagnosed by KDIGO creiteria 6)Incidence of the liver dysfunction (AST or ALTno more than 100) within three months 7)Changes of gut microbiota between preoperative, postoperative and before discharge 8)Change of MMSE from preoperative and postoperative values three months after operation 9)Duration of ICU stay 10)Duration in hospital 11)Mortality in three months | — |
Contacts
Public ContactYuko Ohnishi
National Cerebral and Cardiovascular Center
Outcome results
None listed