Coronary artery disease, valvular disease, pericardial disease, cardiac tumors Valve disease, coronary artery disease
Conditions
Interventions
Subject patients take synbiotics 3 times a day starting 10 days before surgery (up to 14 days).
We perform a stool sample after hospitalization and before surgery and first postoperative stool collect
D058616
Sponsors
Yoshitani Kenji
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients scheduled for cardiac surgery using cardiopulmonary bypass 2) Patients who have more than 10 days between registration and cardiac surgery 3) Patients who are 65 years of age or older at the time of consent 4) Patients who provided written informed consent.
Exclusion criteria
Exclusion criteria: 1) Patients who take other probiotic or synbiotic preparations, within 2 weeks prior to the start of Synprotec until the end of the postoperative delirium evaluation. 2) Patients with an ICDSC score of 3 or higher or MMSE-J score of 21 or lower on the most recent examination prior to enrollment 3) Patients who have difficulty taking the Synprotec (e.g., difficulty taking orally, allergy to the test product, inability to comply with the dosing regimen, etc.) 4) Patients scheduled to receive a left ventricular assist device 5) Patients with a history of treatment for diseases associated with degeneration of the basal ganglia 6) Patients with a history of craniotomy 7) Patients taking antipsychotic drugs 8) Patients diagnosed with dementia and undergoing treatment 9) Patients diagnosed with infective endocarditis 10) Patients with a colostomy 11) Patients diagnosed with inflammatory bowel disease (Crohn's disease, ulcerative colitis) and under treatment 12) Patients diagnosed with and undergoing treatment for collagen disease 13) Patients who have received antibiotics within 2 weeks prior to providing consent 14) Patients who are judged by the principal investigator or subinvestigator to be inappropriate to participate in this study for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Association between synbiotics oral administration and incidence of postoperative delirium within 1 week after surgery (delirium defined as ICDSC score of 3 or more points at least once). Delirium is defined as a score of 3 or more at least once within 1 week. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Incidence rate of MACE (major advanced cardiac event: 2.2 L/min/m2 or less (except for 2.2 L/min/m2 or less at ICU admission), new atrial fibrillation, myocardial infarction, stroke, or heart failure requiring hospitalization) within 3 months after surgery 2) Incidence of postoperative pneumonia,chest X-ray showing pneumonia, CRP (mg/dL) more than 0.3 during hospitalization 3) Incidence of reintubation after 6 hours after extubation 4) Incidence of surgery related infections, wound infection and mediastinitis requiring new antibiotics, within 3 months after surgery, total number of days of antibiotics administered 5) Incidence of postoperative acute kidney injury according to KDIGO criteria within 3 months after surgery 6) Incidence of postoperative liver dysfunction, AST or ALT more than 100 U/L within 3 months after surgery 7) Alteration of the bacterial composition of the intestinal microflora comparing the bacterial count of the preoperative intestinal microflora immediately after the start of the oral postoperative period and before discharge from the hospital. 8) Alterations in tissue-derived exosomes. The effects of synbiotics will be examined by measuring exosomes derived from neurons, oligodendroglial cells, and astrocytes. (Changes will be examined chronologically after induction of anesthesia, at the end of surgery, on the first and second postoperative days, and before discharge from the hospital. In addition, a blood sample will be taken 3 months later to investigate the transition.The association with dementia-related substances will be evaluated. Exosomes will be quantified by Osaka University Health and Counseling Center using an ELISA-based quantification method with a sandwich method of anti-exosome antibodies (CD-9) and anti-neuronal cell antibodies (CD171). The same sandwich method will be used for oligodendroglial cells and astrocytes. We have obtained results that neuronal-derived exosomes are significantly elevated in patients with delirium | — |
Contacts
Public ContactYuko Oonishi
National Cerebral and Cardiovascular Center
Outcome results
None listed