Measurement Of NT-proBNP to Predict Outcomes in Surgery

Study Overview
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Brief Summary
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The team is investigating whether N-terminal pro B-type natriuretic peptide (NT-proBNP) and other cardiac markers are useful for predicting outcomes for patients undergoing vascular surgery. By measuring NT-proBNP before and after surgery, the investigators may be able to determine which patients are at risk of an adverse outcome, such as a heart attack or death.

Detailed Description
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Almost 1 in 5 patients who have elective major vascular surgery experience death or a myocardial infarction (MI) at 18 months post-surgery. Research has shown that peri-operative interventions may improve outcomes for high-risk patients. Cardiac bio-markers may be used to identify these high-risk patients, in particular pre- and post-operative NT-proBNP. Mahla found that by comparing surgery outcomes with NT-proBNP concentrations peri-operatively, high-risk patients could be identified and subsequent therapeutic decisions could be made to minimise adverse outcomes. Van Kimmenade evaluated patients with acute heart failure and found that galectin-3 (Gal-3) was the best predictor of 60-day mortality compared with NT-proBNP and apelin (another cardiac marker), whereas NT-proBNP was the most useful for diagnosing HF. The authors also found that the combination of both markers (Gal-3 and NT-proBNP) have an even higher predictive value for outcome. The predictive role of troponin I (cTnI) has been observed in a paper by Bursi et al. (2005) where patients undergoing elective major vascular surgery were stratified using the American College of Cardiology/American Heart Association (ACC/AHA) guidelines and followed up over a period of 24 months. Patients in every group with an elevated post-operative cTnI (≥100ng/L) were at greater risk of either MI or death. The successful identification of high-risk patients can go on to have interventional risk-reducing pharmacological, therapeutic, diagnostic, or observational measures. Prevention of cardiovascular events, particular for an aging population, can have positive impact on both the patient and society as a whole as it may result in patients maintaining their independence, avoiding major illness, avoiding nursing home care and living longer.

Official Title
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Peri-operative Measurement of NT-proBNP to Predict Outcomes in Patients Undergoing Elective Vascular Surgery

Conditions
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Vascular Surgical Procedure

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are equal to or over 18 years old Patients scheduled to undergo elective surgery for the following procedures: Infrainguinal arterial reconstruction Aortic aneurysm Aorto-bifemoral bypass / or aortic endarterectomy Femoro-popliteal bypass Femoro-distal bypass Femoral endarterectomy Femoro-femoral crossover Axillo-femoral bypass Elective carotid surgery Patients having either general or regional anaesthesia for their surgery Exclusion Criteria:- Patients undergoing emergency surgery Those who are unable or unwilling to give informed consent Patients with unstable coronary syndromes (acute or recent MI with evidence of important ischemic risk by clinical symptoms or stress testing or unstable or severe angina pectoris) Patients with decompensated heart failure (new onset shortness of breath and rales together with echocardiographic evidence of cardiac dysfunction or deterioration of chronic heart failure despite heart failure therapy) Patients with chronic atrial fibrillation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Event-free<br>Patients who have had no negative events (as described in group 2) | |
| Negative event<br>Group 2 - patients with one or more of the following negative events post-operatively: Whether the patient has been prescribed inotropic support Wound infection by assessing use of antibiotics. Length of stay in hospital >1 week Reduced renal function assessed by having any AKI alert during hospital stay Cardiac event within 31 days following surgery Death within 31 days following surgery | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NT-proBNP blood test measured on the day of (pre-) vascular surgery | NT-proBNP blood test measured on the day of (pre-) vascular surgery | 4 days | 
| NT-proBNP blood test measured on the day 4 after (post-) vascular surgery | NT-proBNP blood test measured on the day 4 after (post-) vascular surgery | 4 days | 
| Change in NT-proBNP peri-operatively | Change in NT-proBNP peri-operatively | 4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-, post-, and peri-operative troponin I | Pre-, post-, and peri-operative troponin I | 4 days | 
| Pre-, post-, and peri-operative galectin-3 | Pre-, post-, and peri-operative galectin-3 | 4 days | 
| Pre-, post-, and peri-operative CRP | Pre-, post-, and peri-operative CRP | 4 days | 
| Pre-, post-, and peri-operative creatinine | Pre-, post-, and peri-operative creatinine | 4 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vascular Surgical Procedure, Pro-brain natriuretic peptide (1-76), Natriuretic Peptide, Brain, Troponin I, Galectin 3, Biomarkers, Risk