Clinical trial

Ulinastatin Improves Post-Cardiac Surgery Cognitive Dysfunction by Inhibiting Glycocalyx Degradation: An Observational Study

Name
TJ-IRB20231224
Description
This study is a retrospective, observational study that aims to include patients undergoing cardiac surgery. 1. Evaluate the preventive effect of ursodeoxycholic acid on post-cardiac surgery cognitive dysfunction over the past eight years. 2. Utilize the pre-existing preoperative and postoperative 24-hour plasma samples from previous studies to measure the levels of glycocalyx and its related regulatory factors. 3. Assess the clinical correlation between the measured parameters and patient outcomes.
Trial arms
Trial start
2015-01-01
Estimated PCD
2022-12-30
Trial end
2023-12-30
Status
Completed
Treatment
Ulinastatin
Ulinastatin was pumped continuously during the operation
Size
7065
Primary endpoint
POCD - Postoperative Cognitive Dysfunction
24 hours
Eligibility criteria
Inclusion Criteria: 1. Voluntary participation in the study; 2. Age ≥ 18 years and ≤ 80 years; 3. Patients undergoing heart surgery: (coronary artery bypass grafting, heart valve replacement surgery, Morrow procedure, aortic dissection surgery). Exclusion Criteria: 1. Patients experiencing adverse events during the surgery; 2. Recipients of solid organ or bone marrow transplants; 3. Patients with autoimmune diseases, tumors, or who have received high-dose steroids or immunosuppressive therapy within the past 2 months; 4. Deemed unsuitable for participation in this study by the researchers.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 7065, 'type': 'ACTUAL'}}
Updated at
2024-02-20

1 organization

1 drug

1 indication

Organization
Qin Zhang