Dynamics of Immune Map and Outcomes After On-pump Cardiac Surgery: Protocol for a Prospective Cohort Study

Study Overview
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Brief Summary
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Although systemic inflammatory response induced by cardiopulmonary bypass is believed as one of main reasons for these adverse events, the involved mechanism is still unclear.This cohort study would include patients undergoing on-pump valve surgery or CABG. By detecting the changes of immune cell expression profile and inflammatory related substances in blood, the spatiotemporal change curve of immune function of patients is drawn for avoiding or treating adverse events.

Official Title
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Dynamics of Immune Map and Outcomes After On-pump Cardiac Surgery: Protocol for a Prospective Cohort Study

Conditions
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On-pump Valve Surgery or CABG

Intervention / Treatment
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* Procedure: On-pump valve surgery or CABG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: (1) participants aged over 18 years; (2) Participants who scheduled for valve replacement or valvuloplasty, coronary artery bypass under CPB. Exclusion Criteria: (1) participant with a cognitive or mental disorder who is unable to sign an informed consent form; (2) suffering from basic immune system and blood system diseases; (3) pregnancy; (4) preoperative radiotherapy and chemotherapy; (5) receive immunosuppressive drugs within six months;(6) Expected survival time less than 2 years;(7) participated in other intervention clinical trials within 30 days before operation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Complication group<br>Postoperative complications are defined as postoperative death, vital organ dysfunction, and mechanical ventilation duration greater than 24 hours.The vital organ dysfunction includes new developed acute kidney injury, long-term low cardiac output, severe liver function injury and neurological function injury. The time of occurrence is defined as from the beginning of surgery to 30 days after surgery or to discharge from hospital. | Procedure: On-pump valve surgery or CABG<br>* On-pump valve surgery or coronary arterial bypass grafting<br>|
| Non-complication group<br>Patients with none of postoperative complications which showed in Complication group. The time of occurrence is defined as from the beginning of surgery to 30 days after surgery or to discharge from hospital. | Procedure: On-pump valve surgery or CABG<br>* On-pump valve surgery or coronary arterial bypass grafting<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| composite outcome | the incidence of vital organ injury, which is defined as a composite measure, including postoperative death, vital organ dysfunction, and mechanical ventilation duration greater than 24 hours. And the vital organ dysfunction includes new kidney injury, long-term low cardiac output, severe liver function injury and neurological function injury. | From the beginning of surgery to 30 days after surgery or to discharge from hospital | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infection |  | From the beginning of surgery to 30 days after surgery or to discharge from hospital] | 
| MACCE | including all-cause mortality, myocardial infarction, severe arrhythmias and stroke | From the beginning of surgery to 30 days after surgery or to discharge from hospital] | 
| Acute lung injury | Acute onset of bilateral infiltrates on the chest readiograph and hypoxaema(PaO2/Fi O2 ratio <300) in the absence of clincial evidence of left atrial hypertension | From the beginning of surgery to 30 days after surgery or to discharge from hospital] | 
| Gastrointestinal complications | including gastrointestinal bleeding and intestinal ischemia | From the beginning of surgery to 30 days after surgery or to discharge from hospital |