Pharmacological Action Clinical Trial
Official title:
Ulinastatin Improves and Prevents Cardiac Dysfunction Induced by Cardiopulmonary Bypass by Reducing Cardiac Endothelial Permeability
Verified date | March 2024 |
Source | Tongji Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 236 |
Est. completion date | December 30, 2024 |
Est. primary completion date | December 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei |
Lead Sponsor | Collaborator |
---|---|
Qin Zhang |
China,
Atal SS, Atal S. Ulinastatin - a newer potential therapeutic option for multiple organ dysfunction syndrome. J Basic Clin Physiol Pharmacol. 2016 Mar;27(2):91-9. doi: 10.1515/jbcpp-2015-0003. — View Citation
Liu Y, Wang YL, Zou SH, Sun PF, Zhao Q. Effect of high-dose ulinastatin on the cardiopulmonary bypass-induced inflammatory response in patients undergoing open-heart surgery. Chin Med J (Engl). 2020 Jun 20;133(12):1476-1478. doi: 10.1097/CM9.0000000000000 — View Citation
Xu HY, Rong XS, Wang DP, Jiang SY, Zang ZD, Xia W, Zhang F, Yan J. Effect of urinary trypsin inhibitor on inflammatory cytokines and organ function in patients with cardiopulmonary bypass. Eur Rev Med Pharmacol Sci. 2017 May;21(9):2220-2225. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cardiac function | Echocardiographic detection | 24 hours | |
Primary | Inflammatory marker | Detection of CRP | 24 hours | |
Primary | Inflammatory markers | Detection of IL6 | 24 hours | |
Primary | TK/B1R/MMP3 signaling | Detection levels of tissue kallikrein, B1R and MMP3 | 24 hours | |
Secondary | Survival time | Questionnaire | 28 days |
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