Effect of Synbiotics on Postoperative Delirium after Elective Cardiac Surgery

JRCT ID: jRCTs051210080

Registered date:07/09/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Cardiac valvular disease, coronary artery disease
• Date of first enrollment: 29/10/2021
• Target sample size: 184
• Study type: Interventional
• Intervention(s): 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 the first postoperative oral ingestion, LBG-P is administered for senven days three times per day.

Outcome(s)

• Primary Outcome: Association between symbiotics and the incidence of postoperative delirium (ICDSC score of 3 or higher is defined as delirium) in postoperative one week

Secondary Outcome

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)Exosomes from brain tissue Exosomes from neurons, oligodendroglial cells, and astrocytes will be measured to examine the effects of synbiotics among preoperative, postoperative periods and before discharge.In addition, a blood sample will be taken 3 months later to investigate the transition. The association with dementia-related substances (see 4.4) will be evaluated.
9)Change of MMSE from preoperative and postoperative values three months after operation
10)Duration of ICU stay
11)Duration in hospital
12)Mortality in three months

Key inclusion & exclusion criteria

• Age minimum: >= 65age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Yoshitani Kenji
• Source(s) of Monetary Support: National Cerebral and Cardio vascular Center