Clinical trial

Ulinastatin Improves and Prevents Cardiac Dysfunction Induced by Cardiopulmonary Bypass by Reducing Cardiac Endothelial Permeability

Name
TJ-IRB20220831
Description
This project explores the role and mechanism of ulinastatin in preventing cardiac dysfunction caused by cardiopulmonary bypass by reducing cardiac endothelial permeability through clinical research. Our previous basic research has found that inhibiting the TK/B1R/ARNT/MMP3/iNOS signaling axis in the acute phase of cardiac R/I can reduce the permeability of cardiac endothelial cells, reduce cardiac edema and improve cardiac function (this part has been completed) . This study intends to investigate the effects of ulinastatin on 24-hour cardiac function and prognosis in patients undergoing cardiac surgery undergoing cardiopulmonary bypass (cardiac function, inflammatory indicators, coagulation function, capillary leakage indicators, 28-day survival time, CCU time). At the same time, we observed the dynamic changes of TK/B1R/MMP3 during cardiopulmonary bypass in patients undergoing cardiac surgery and explored its relationship with prognosis, as well as the effect of ulinastatin intervention on TK/B1R/MMP3 before and after cardiopulmonary bypass.
Trial arms
Trial start
2022-09-16
Estimated PCD
2024-12-30
Trial end
2024-12-30
Status
Recruiting
Treatment
Ulinastatin
On the basis of conventional treatment, according to the instructions or previous research doses (general anesthesia and tracheal intubation, after cardiopulmonary bypass transfer starts): 10,000 U/kg Ulinastatin (National Medicine Approval No. H19990134, Guangdong Tianpu Biochemical Pharmaceutical Co., Ltd. Co., Ltd., Guangzhou, China) was dissolved in 50 ml of normal saline for 1 hour and pumped through the central vein.
Arms:
Ulinastatin
saline
On the basis of conventional treatment, 50 ml of normal saline for 1 hour and pumped through the central vein.
Arms:
Conventional treatment group
Size
236
Primary endpoint
Cardiac function
24 hours
Inflammatory marker
24 hours
Inflammatory markers
24 hours
TK/B1R/MMP3 signaling
24 hours
Eligibility criteria
Inclusion Criteria: 1. Voluntarily sign the informed consent; 2. Age ≥18 years old and ≤70 years old; 3. Patients receiving cardiopulmonary bypass 4. Patients undergoing heart valve replacement surgery, major vascular surgery, and other cardiac surgery Exclusion Criteria: 1. Severe cardiac insufficiency before surgery (EF\<50%, cardiogenic shock); 2. Patients with adverse events during surgery (such as cardiac arrest, etc.); 3. Solid organ or bone marrow transplant recipients; 4. pregnant women; 5. Have a history of allergy to ulinastatin or any of its ingredients; 6. Suffering from autoimmune diseases, tumors, or received high-dose hormones, immunosuppressive drugs, etc. within 2 months; 7. The researcher judges that it is not suitable to participate in this research.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '1. Voluntarily sign the informed consent;\n2. Age ≥18 years old and ≤70 years old;\n3. Patients receiving cardiopulmonary bypass\n4. Patients undergoing heart valve replacement surgery, major vascular surgery, and other cardiac surgery', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 236, 'type': 'ESTIMATED'}}
Updated at
2024-04-01

1 organization

1 drug

1 indication

Organization
Qin Zhang