Copeptin and HFABP in Cardiac Surgery

Study Overview
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Brief Summary
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In-hospital mortality after cardiac surgery ranges from 2-6%. Many patients suffer from major adverse cardiovascular events (MACE) which results in impaired disability-free survival. Troponin plays the central role in identifying MACE. However, interpretation after cardiac surgery is difficult due to ischemia-reperfusion-injury and direct surgical trauma. While the 4th universal definition of type 5 myocardial infarction uses the 10 x ULN as cut-off, >90% of patients after on-pump procedures exceed this cut-off. Clinical consequences are unclear. The dynamic of Copeptin and Heart-type fatty acid binding protein (H-FABP) concentrations starts very early, i.e. several hours before Troponin. The investigators plan a prospective multicenter cohort study to evaluate 1) the independent association between Copeptin and H-FABP with disability -free survival and MACE after cardiac surgery; 2) the predictive gain of their addition to the Euroscore II; 3) the independent association between H-FABP and acute kidney injury.

Detailed Description
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The initial patient visit will take place after screening of patients and eligibility assessment and no later than on the day before surgery (day -1). After provision of patient information and written informed consent, baseline data will be extracted from clinical source documents. Blood will be sampled prior to induction (Troponin), upon arrival in the intensive care unit (Troponin, HFABP and Copeptin), and on postoperative day 1 and 2 (Troponin). Sampling will occur as far as possible concurrently to clinically indicated blood samples. Blood samples will be analyzed in a certified laboratory. All patients will be contacted after 30 days and 12 months by E-Mail, postal mail and/or phone call to obtain for the 12-item WHODAS 2 and information on potential events.

Official Title
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Predictive Value of Copeptin and Heart-Type Fatty Acid Binding Protein in Cardiac Surgery - A Multicenter Prospective Cohort Study

Conditions
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Coronary Artery Disease, Valvular Heart Disease

Intervention / Treatment
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* Diagnostic Test: Blood sampling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult (≥ 18 years of age) Elective surgery On-pump cardiac surgery (CABG and/or valvular surgery) Exclusion Criteria: Heart transplantation (HTX) ACS at presentation (< 14 days) Emergency surgery Preoperative inotropic or mechanical circulatory support Left or right ventricular assist device implantation Unwilling or unable to provide consent Inability to follow the procedures of the study, e.g. due to language barriers, psychiatric disorders, dementia

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 |
| --- | --- |
| Cardiac Surgery<br>Adult Patients undergoing elective on-pump cardiac surgery (i.e. Coronary artery bypass graft surgery (CABG) and/or valvular surgery) | Diagnostic Test: Blood sampling<br>* Blood will be sampled from enrolled patients and analyzed for levels of troponin, copeptin and heart-type fatty acid binding protein (HFABP).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disability-free survival | Disability is defined as a persistent (at least 6 months) impairment in health status, as measured by the 12-item WHODAS 2.0 score, of at least 24 points when using response scores of 1-5 for each item, reflecting a disability level of at least 25% and being the threshold point between 'disabled' and 'not disabled' as per WHO guidelines. | 1 years after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days alive and out of hospital | Patient-centered outcome to measure morbidity and mortality after surgery | At 30 days and 12 months after surgery | 
| Major adverse cardiovascular events (MACE) | Defined as non-fatal cardiac arrest, acute myocardial infarction, congestive heart failure or transfer to a higher unit of care, atrial fibrillation or stroke | At 30 days and 12 months after surgery | 
| All cause mortality | Evaluate mortality after cardiac surgery | At 30 days and 12 months after surgery | 
| Length of ICU-stay | To observe the length and/or readmission rate of intensive care unit stay | At 30 days | 
| Acute kidney injury (AKI) | As defined by the three-stage KDIGO (Kidney Disease: Improving Global Outcome) classification of severity | At 30 days |