Role of High Mobility Group Box 1 as a Prognostic Biomarker in Patients Undergoing Valvular Heart Surgery

Completed

• Conditions: Valvular Heart Disease
• Interventions: Procedure: Blood sampling

• Registration Number: NCT02490644
• Lead Sponsor: Yonsei University

Brief Summary

One of the most important factor that affects the post op complication of the cardiac surgery is systemic inflammation. Valvular heart surgery requires cardiopulmonary bypass and cardioplegic arrest, which can arouse the ischemic/reperfusion injury causing myocardial damage and inflammatory response. These myocardial damage and inflammatory response can cause multi-organ failure or even death.

Detailed Description

One of the most important factor that affects the post op complication of the cardiac surgery is systemic inflammation. Valvular heart surgery requires cardiopulmonary bypass and cardioplegic arrest, which can arouse the ischemic/reperfusion injury causing myocardial damage and inflammatory response. These myocardial damage and inflammatory response can cause multi-organ failure or even death.

High-mobility group protein B1 (HMGB1) is a protein which is encoded by the HMGB1 gene in human. HMGB1 is secreted by immune cells (like macrophages, monocytes and dendritic cells). Activated macrophages and monocytes secrete HMGB1 as a cytokine mediator of Inflammation. There are many studies suggesting the relationship between HMGB1 and acute coronary syndrome, myocardial ischemic/reperfusion injury, atherosclerosis, heart failure and other cardiac disease as a marker for inflammatory response. However, there are no other study evaluating HMGB1 as a prognostic factor after valvular surgery, so far.

Study Timeline

• Study Start: 2015-01-12
• Study First Submitted: 2015-06-30
• Study First Submitted QC: 2015-07-01
• Study First Posted: 2015-07-07
• Primary Completion: 2017-09-29
• Study Completion: 2017-09-29
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-27
• Last Update Posted: 2019-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• age ≥ 20
• patients undergoing aortic valve surgery or more than single valve surgery

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Exclusion Criteria

• age < 20
• patients undergoing single mitral valve surgery
• history of open heart surgery
• emergency surgery
• history of steroid medication
• infective disease and/or malignant tumor
• coronary artery bypass surgery or aortic replacement surgery

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MGB1 in valvular heart surgery	Blood sampling	Evaluation of the high mobility group box 1 as a prognostic biomarker in patients undergoing valvular heart surgery

Primary Outcome Measures

Name	Time	Method
concentration of HMGB1	collect blood sample right before the surgery after induction of anesthesia	The relationship between concentration of HMGB1 and post op prognosis in patients undergoing valvular heart surgery

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of