The Kallikrein-Kinin System in Cardiac Surgery

Cardiosurgery Clinical Trial

Official title:

The Involvement of the Kallikrein-Kinin System in the Pathogenesis of Postoperative Injury in Cardiac Surgery: An Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06080295
• Other study ID #: TJ-IRB20230932
• Status: Recruiting
• Start date: September 20, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: January 2024
• Source: Tongji Hospital
• Contact: Qin Zhang, phd
• Phone: 15717154768
• Email: qzhang8[@]tjh.tjmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

We aimed to established an interlink among the kallikrein-kinin system (KKS), endothelial dysfunction and cardiac inflammation in response to cardiosurgery , using clinic investigation.

Description:

The KKS, which is located on the vascular endothelium, plays a pivotal role in maintaining cardiovascular homeostasis. Tissue kallikrein (TK), a serine protease and a key enzyme of the KKS, is responsible for cleaving low-molecular-weight kininogen into bradykinin and kallidin. Under normal physiological conditions, the activation of the B2 receptor (B2R)/endothelial nitric oxide synthase (eNOS) signaling pathway leads to the transient release of nitric oxide (NO), resulting in cardiovascular protection. However, during reperfusion injury, the activation of the B1 receptor (B1R)/inducible nitric oxide synthase (iNOS) pathway leads to excessive NO production, promoting inflammation and cellular injury. Therefore, it is hypothesized that the KKS plays a critical role in the early stages of reperfusion injury during cardiac surgery with cardiopulmonary bypass.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 308
• Est. completion date: December 30, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1) Willing to participate in the study. 2) Age = 18 years and = 80 years. 3) Patients undergoing cardiac surgery: (coronary artery bypass grafting, heart valve surgery, Morrow operation, aortic dissection surgery).

Exclusion Criteria:

1) Patients with heart failure. 2) Patients experiencing adverse events during surgery. 3) Solid organ or bone marrow transplant recipients. 4) Patients with autoimmune diseases, tumors, or those who received high-dose steroid or immunosuppressant therapy within the past two months. 5) Deemed unsuitable for participation in this study by the researchers' judgment.

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Related Conditions & MeSH terms

• Cardiosurgery

Locations

Country	Name	City	State
China	Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Qin Zhang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	survival	survival and KKS related factors levels	24 hours
Primary	Cardiac function	echocardiography and Myo-cardial enzymonram	24 hours
Secondary	survival	survival and clinical symptom	28 days