The Kallikrein-Kinin System in Cardiac Surgery

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

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

Study Overview

• Status: Recruiting
• Conditions: Cardiosurgery

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 308

Contacts and Locations

• Study Contact: Name: Qin Zhang, phd; Phone Number: 15717154768; Email: qzhang8@tjh.tjmu.edu.cn
• Study Contact Backup: Name: Xiao Ran, phd; Phone Number: 15926207366; Email: ranxiao1001@tjh.tjmu.edu.cn

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Recruiting
      • Tongji Hospital, Tongji Medical college, Huazhong University of Science and Technology
      • Contact: Qin Zhang, phd; Phone Number: 15717154768; Email: qzhang8@tjh.tjmu.edu.cn
      • Principal Investigator: Qin Zhang, phd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients undergoing cardiac surgery: (coronary artery bypass grafting, heart valve surgery, Morrow operation, aortic dissection surgery).

Description

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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Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
survival	survival and KKS related factors levels	24 hours
Cardiac function	echocardiography and Myo-cardial enzymonram	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
survival	survival and clinical symptom	28 days

Collaborators and Investigators

• Sponsor: Qin Zhang
• Investigators: Principal Investigator: Qin Zhang, phd, Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2023
• Primary Completion (Estimated): July 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: October 6, 2023
• First Submitted That Met QC Criteria: October 6, 2023
• First Posted (Actual): October 12, 2023

Study Record Updates

• Last Update Posted (Actual): January 12, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: KKS; tissue kallikrein; MMPs;cardiosurgery;cardiopulmonary bypass
• Other Study ID Numbers: TJ-IRB20230932

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No