Heart Valve Surgery
Conditions
Interventions
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
45 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The patients ranged in age from 45 to 75 years; 2. In the screening period, the renal and liver function of the patient is normal, which refers to the following clinical biochemical results: (1) Serum creatinine 50 mL/min (calculated using the Cockcroft-Gult formula); (2) Serum alanine aminotransferase = 8.5 g/dL (SI units: >= 85 g/L or 5.28 mmol/L); (2) WBC count >= 3.5 * 10^3 cells / µL (SI unit: >= 3.5 * 10^9 cells/L); (3) Neutrophils count >= 1.5 * 10^3 cells/L (SI unit: >= 1.5 * 10^9 cells/L); (4) Platelet count >= 100 * 10^3 cells / µL (SI unit: >= 100 * 10^9 cells/L). 4. Patients can understand the full nature and purpose of the study, including possible risks and side effects, cooperate with the investigator, understand oral and/or written instructions, and comply with the requirements of the entire study; 5. Patients (or legal guardians, if applicable) have been informed of the full nature and purpose of the study, including possible risks and side effects, given sufficient time and opportunity to read or understand the relevant information, and signed and dated written informed consent before enrolment; 6. Intravenous access is sufficient for blood sample collection and IV administration according to the study protocol; 7. The patient is in line with the indications of heart valve surgery; 8. There was no evidence of active infection during the screening period; 9. The patients with 12 years of education and above can successfully answer all the cognitive scale questions during the screening period.
Exclusion criteria
Exclusion criteria: 1. The investigator believes that the subjects have conditions that may interfere with the study results; 2. Subjects with evidence of active liver disease (liver function test results: alanine aminotransferase [ALT] or aspartate aminotransferase [AST] >= 2 times the upper limit of normal [ULN]) or with chronic active hepatitis B or hepatitis C within 1 month prior to kidney transplantation; 3. Active systemic infection requiring antibiotics in the first week before surgery; 4. patients suffering from one or more of the following diseases: (1) Classified as obese (BMI >= 30 kg/m2); (2) Diabetes remains uncontrolled even after insulin treatment; (3) Uncontrolled hypertension (defined as systolic blood pressure >= 180 mmHg or diastolic blood pressure >= 100 mmHg); (4) A history of lymphoma or tissue-proliferative disease or bone marrow; (5) A history of organ transplantation, including corneas; (6) Has any clinically significant uncontrolled respiratory disease, including but not limited to chronic obstructive lung disease, asthma bronchiectasis or pleural effusion; (7) Previous diagnosis or suspected demyelinating diseases, including multiple sclerosis, Guillain-Barre syndrome, etc.; (8) Any disease that significantly affects the nervous system.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative cognitive dysfunction; | — |
Secondary
| Measure | Time frame |
|---|---|
| Inflammatory cytokines;Renal Function;Incidence of postoperative complications;Incidence of cardiac autonomic reentry after extracorporeal circulation;Total hospitalization days;Incidence of postoperative mechanical ventilation for more than 24 hours and reintubation of trachea; | — |
Countries
China
Contacts
Public ContactXian-Fu Lu
The First Affiliated Hospital of Anhui Medical University
Outcome results
None listed